The French Competition Authority recently fined several companies for no-poach agreements, following similar action by the European Commission in the online food delivery sector. These decisions mark a sharp escalation in labor market antitrust enforcement and give further support to the position that no-poach agreements qualify as “by object” violations. Companies should exercise caution in drafting employment contracts and consider the least restrictive ways possible to (1) protect investments in technology/know-how and human capital and (2) retain talent.
This LawFlash summarizes the key takeaways from the landmark decisions by the European Commission (EC) and French Competition Authority (FCA), as well as their practical implications for businesses.
CASE LAW AT THE EU LEVEL
In November 2023, the EC raided the premises of food delivery companies Delivery Hero and Glovo in relation to suspected no-poach agreements violating EU antitrust rules.[1] The formal investigation was initiated on July 23, 2024, based in part on concerns that the two companies may have agreed not to poach each other’s employees before Delivery Hero acquired full control over Glovo.[2] According to the EC, these practices may have been facilitated by Delivery Hero’s purchase of a non-controlling minority shareholding in Glovo in 2018.
On June 2, 2025, the EC fined Delivery Hero and Glovo a total of €329 million for participating in a cartel.[3] According to the EC, the two companies engaged in multi-layered anticompetitive coordination over four years following Delivery Hero’s acquisition of a minority stake in Glovo. This included exchanging commercially sensitive information, allocating geographic markets, and agreeing not to poach each other’s employees.
Specifically, the shareholders’ agreement signed at the time Delivery Hero acquired its minority stake in Glovo contained limited reciprocal no-hire clauses[4] for certain employees. Shortly thereafter, this arrangement evolved into a general agreement not to actively approach each other’s employees. Both companies ultimately decided to settle the case with the EC.
The pace of the case—approximately one year from the opening of the formal investigation to the adoption of the infringement decision—is unusually fast by the EC’s standards for cartel cases and is likely explained by the fact that, faced with the evidence adduced by the EC, the companies concerned decided to settle the case.
It remains to be seen whether any follow-on actions will materialize after this decision. Such actions could potentially be brought by individuals harmed by the anticompetitive conduct, similar to cases seen in the United States, where no-poach agreements have been under scrutiny for a longer period. Specifically, employees who were subject to the no-poach agreement may seek compensation for lost job opportunities resulting from the anticompetitive no-poach agreements (see further below).
CASE LAW AT THE FRENCH LEVEL
As noted in our prior analysis, in 2023, the FCA notified several companies active in the engineering, technology consulting, and IT services sectors that it would investigate potential violations on labor markets.[5] On June 11, 2025, the FCA sanctioned four companies for engaging in general no-poach agreements. While the full decision is not public yet, the FCA published a summary of the decision in a press release.[6]
The anticompetitive practices came to light following a leniency application submitted by Ausy, which notably disclosed the existence of a non-solicitation agreement with Alten. Based on the information provided by Ausy, the FCA obtained judicial authorization from the “juge des libertés et de la détention”—a French judge competent for overseeing the legality of certain investigative measures—to conduct dawn raids at the following companies active in the engineering and IT services sector: Alten, Bertrand, Expleo, and Atos.
The FCA dawn raids uncovered two separate sets of restrictive practices between Ausy and Alten, on the one hand, and Expleo and Bertrandt, on the other:
Ausy and Alten: Between 2007 and 2016, the two companies entered into gentlemen’s agreements[7] not to poach business managers. These agreements prohibited both active solicitation and passive acceptance of applications from each other’s employees. No limits were placed on the duration of these arrangements or on the scope of business managers covered.
Expleo and Bertrandt: Between February and September 2018, the two companies similarly entered into gentlemen’s agreements not to poach each other’s employees.
The FCA imposed fines totaling €29.5 million (around $34 million) on Alten, Expleo, and Bertrandt for taking part in these gentlemen’s agreements. Alten received the highest fine (€24 million). Ausy was not sanctioned, as it benefited from full immunity under the French leniency program. Expleo and Bertrandt were fined lower amounts. The reasoning behind the FCA’s fine calculation is not yet publicly available and will become clearer once the full decision is published, although we expect that differences in the duration of the practices may account for the variation in fine levels.
The fine appears to be significantly lower than the FCA’s previous decision. In 2017, the FCA imposed fines totaling €302 million on the three leading manufacturers of polyvinyl chloride (PVC) and linoleum floor coverings for price fixing and other practices, including wage-fixing and no-poach agreements.[8] While this might be partly due to the absence of other traditional anticompetitive practices beyond no-poach arrangements, the reasoning is not yet known.
In addition to the above, Expleo and Bertrandt, on the one hand, and Ausy and Atos, on the other, also included non-solicit clauses in partnership agreements. However, the FCA decided not to sanction such clauses because they were limited in duration and scope (they only concerned certain categories of employees, certain projects, etc.) under the specific circumstances of this case. This does not prevent the FCA from sanctioning such clauses in the future, under different factual circumstances.
KEY TAKEAWAYS
It is now clear from the above EC and FCA decisions that no-poach agreements qualify as “by object” restrictions and amount to supply source sharing.
In the Delivery Hero/Glovo decision, the EC qualified these practices, including the no-poach agreement, as a single and continuous infringement amounting to a “by object” restriction (i.e., a restriction inherently harmful to competition—similar to “per se” violations under US antitrust laws). Similarly, the FCA found that the gentlemen’s agreements on no-poach constituted “by object” restrictions.
This is in line with the EC’s May 2024 Antitrust in Labour Markets policy brief, which announced the EC’s intention to sanction no-poach agreements as “by object” restrictions.
The above approach was endorsed by the European Court of Justice’s recent decision in the FIFA v. BZ case, where the court referred to collusive behavior consisting of limiting or controlling, in certain sectors or on certain markets, “the recruitment of highly skilled workers” as a possible restriction by object.[9]
Advocate General (AG) Nicholas Emiliou’s opinion of May 15, 2025 in the Portuguese football clubs case provides additional support for this argument.[10] AG Emiliou found that no-poach agreements, unless ancillary to transactions, have “all the characteristics to be considered prima facie restrictive of competition ‘by object.’”[11] AG Emiliou reasoned that, instead of competing to recruit the best employees—by offering higher salaries and/or better working conditions and opportunities—the companies “lock in” their staff, creating a “freezing effect” on the terms of employment. This leads to a suboptimal allocation of human resources, reduced efficiency and innovation, and lower wages for workers. Both the labor market and, potentially, the output market (products/services of the company) are thus negatively affected. Accordingly, AG Emiliou concluded that the economic rationale of most no-poach agreements between competitors is anticompetitive.
While the EC decision concerns no-poach agreements in the context of other traditional anticompetitive practices, the FCA decision is the first decision where no-poach is the central theory of harm. This demonstrates that the FCA intends to treat no-poach agreements as standalone infringements warranting sanction, even in the absence of price-fixing or market-sharing practices. The EC could also sanction no-poach on a standalone basis in the future.
The application of antitrust to labor markets is sector-agnostic. The EC decision concerned the online food delivery sector, while the FCA decision concerned the engineering, technology consulting, and IT services sectors. In this regard, the FCA previously underlined in a report on the generative AI sector that skilled personnel are considered key in the upstream generative AI value chain (we refer to our prior analysis in this regard). In the decision at hand, the FCA reiterates that the digital sector is marked by a scarcity of talent and the strategic importance of human resources.
The EC and FCA decisions confirm that all levels of employees are covered, from business managers in the FCA decision to any employee in the EC decision.
These decisions at both the EU and the French national level signal firm enforcement intentions. This is illustrated not only by the significant fine imposed by the EC (€329 million), but also by the FCA’s requirement that the sanctioned companies publish the decision on LinkedIn and in the journal Le Monde Informatique.
As noted above, this could become fertile ground for damages claims, especially if plaintiffs firms and cartel litigation finance companies decide to aggressively pursue such cases. Anecdotal evidence reported on July 7,2025 by the French newspaper Le Figaro identified examples of:
An applicant “hitting a wall” when seeking a job with a competitor company that had an arrangement with his employer effectively blocking any chance of a move;
An applicant having a job offer withdrawn as a result of pressure by her employer on the competitor, with which there was an arrangement;
The same applicant subsequently facing retaliation by her employer (in the form of no pay increase, but additional workload) such that she viewed her career as being “on hold”;
Senior managers only being able to escape such restrictive situations by creating their own consulting companies.
Additionally, the Delivery Hero/Glovo decision shows that antitrust scrutiny can arise from an acquisition of minority shareholdings in a competitor, because this can create collusion risks, particularly through unlawful information exchanges or market sharing. Companies should therefore implement robust guardrails to ensure that any governance rights are strictly limited to what is necessary for keeping the value of the investment and similarly limit exchanges of commercially sensitive information.
The implications of these cases for merger control are important. The Spanish National Competition Authority (CNMC) cleared Delivery Hero’s acquisition of full control over Glovo in 2022, following a Phase I review. In contrast, the earlier minority shareholding acquisition was not subject to any ex-ante merger review simply because it was not reportable under merger control rules.[12] Nonetheless, the EC later reviewed the restrictive practices in the context of the minority shareholding acquisition under the antitrust lens, looking at them ex post facto.[13]
A comparable situation occurred in France. In its decision in the meat-cutting sector,[14] the FCA confirmed that it can investigate and sanction non-reportable transactions (i.e., ones that fall outside the merger control rules) under anti-collusion rules.[15] At EU level, following the Towercast judgement,[16] it was already clear that competition authorities can review non-reportable transactions under abuse of dominance rules.[17]
In the French meat-cutting case, the companies argued that a merger cannot be reviewed ex post facto under antitrust rules where the merger was not reportable under merger control rules.[18] The FCA rejected this non bis in idem (double jeopardy) defense, explaining that the transactions had not been reportable under merger control and thus had not been previously reviewed or cleared.
The Delivery Hero/Glovo case gave the EC the opportunity to confirm, as the FCA did in its decision in the meat-cutting sector, that it can review non-reportable transactions under Article 101 TFEU ex post facto.
Legal, human resources, and compliance departments across all industries will have to exercise caution in drafting employment contracts and consider the least restrictive ways possible to protect investments in technology/know-how and human capital and retain talent. For example, alternatives to no-poach agreements, depending on the jurisdiction, may include (1) nondisclosure agreements, (2) incentives to stay with an employer for a minimum amount of time (such as a retention bonus payable subject to the employee’s continued service with the company until a certain date), or (3) narrowly tailored noncompete clauses. However, noncompete clauses are subject to increasingly restrictive judicial analysis, making their application complex and costly. It follows from the above decisions that businesses should avoid general agreements with undetermined duration and unrestricted scope.
Given the legal differences in domestic labor laws in the EU member states—and beyond—and the fact that each case will turn on its specific facts and circumstances, tailored advice from local counsel will be crucial on a case-by-case basis.
AI code editors have quickly become a mainstay of software development, employed by tech giants such as Amazon, Microsoft, and Google.
In an interesting twist, a new study suggests AI tools made some developers less productive.
Experienced developers using AI coding tools took 19% longer to complete issues than those not using generative AI assistance, according to a new study from Model Evaluation & Threat Research (METR).
Even after completing the tasks, participants couldn’t accurately gauge their own productivity, the study said: The average AI-assisted developers still thought their productivity had gained by 20%.
How the study was set up
METR’s study recruited 16 developers with large, open-source repositories that they had worked on for years. The developers were randomly assigned into two groups: Those allowed to use AI coding assistance and those who weren’t.
The AI-assisted coders could choose which vibe-coding tool they used. Most chose Cursor with Claude 3.5/3.7 Sonnet. Business Insider reached out to Cursor for comment.
Developers without AI spent over 10% more time actively coding, the study said. The AI-assisted coders spent over 20% more time reviewing AI outputs, prompting AI, waiting on AI, or being idle.
While participants without AI use spent more time actively coding, AI-assisted participants spent more time prompting and waiting for AI, reviewing its output, and idling.
METR
A ‘really surprising’ result — but it’s important to remember how fast AI tools are progressing
METR researcher Nate Rush told BI he uses an AI code editor every day. While he didn’t make a formal prediction about the study’s results, Rush said he jotted down positive productivity figures he expected the study to reach. He remains surprised by the negative end result — and cautions against taking it out of context.
“Much of what we see is the specificity of our setting,” Rush said, explaining that developers without the participants’ 5-10 years of expertise would likely see different results. “But the fact that we found any slowdown at all was really surprising.”
Steve Newman, serial entrepreneur and cofounder of Google Docs, described the findings in a Substack post as “too bad to be true,” but after more careful analysis of the study and its methodology, he found the study credible.
Related stories
Business Insider tells the innovative stories you want to know
Business Insider tells the innovative stories you want to know
“This study doesn’t expose AI coding tools as a fraud, but it does remind us that they have important limitations (for now, at least),” Newman wrote.
The METR researchers said they found evidence for multiple contributors to the productivity slowdown. Over-optimism was one likely factor: Before completing the tasks, developers predicted AI would decrease implementation time by 24%.
For skilled developers, it may still be quicker to do what you know well. The METR study found that AI-assisted participants slowed down on the issues they were more familiar with. They also reported that their level of experience made it more difficult for AI to help them.
AI also may not be reliable enough yet to produce clean and accurate code. AI-assisted developers in the study accepted less than 44% of the generated code, and spent 9% of their time cleaning AI outputs.
Ruben Bloom, one of the study’s developers, posted a reaction thread on X. Coding assistants have developed considerably since he participated in February.
“I think if the result is valid at this point in time, that’s one thing, I think if people are citing in another 3 months’ time, they’ll be making a mistake,” Bloom wrote.
METR’s Rush acknowledges that the 19% slowdown is a “point-in-time measurement” and that he’d like to study the figure over time. Rush stands by the study’s takeaway that AI productivity gains may be more individualized than expected.
“A number of developers told me this really interesting anecdote, which is, ‘Knowing this information, I feel this desire to use AI more judiciously,’” Rush said. “On an individual level, these developers know their actual productivity impact. They can make more informed decisions.”
HSBC has become the first UK bank to leave the global banking industry’s net zero target-setting group, as campaigners warned it was a “troubling” sign over the lender’s commitment to tackling the climate crisis.
The move risks triggering further departures from the Net Zero Banking Alliance (NZBA) by UK banks, in a fresh blow to international climate coordination efforts.
HSBC’s decision follows a wave of exits by major US banks in the run-up to Donald Trump’s inauguration in January. His return to the White House has spurred a climate backlash as he pushes for higher production of oil and gas.
HSBC was a founding member of the NZBA at its launch in 2021, with the bank’s then chief executive, Noel Quinn, saying it was vital to “establish a robust and transparent framework for monitoring progress” towards net zero carbon-emission targets.
“We want to set that standard for the banking industry. Industry-wide collaboration is essential in achieving that goal,” Quinn said.
Convened by the UN environment programme’s finance initiative but led by banks, the NZBA commits members to aligning their lending, investment and capital markets activities with net zero greenhouse-gas emissions by 2050 or earlier.
Six of the largest banks in the US – Citigroup, Bank of America, Morgan Stanley, Wells Fargo and Goldman Sachs – left the NZBA after Trump was elected.
UK lenders including Barclays, Lloyds, NatWest, Standard Chartered and Nationwide were still listed as members as of Friday afternoon.
HSBC’s decision to leave the alliance comes just months after it announced it was delaying key parts of its climate goals by 20 years and watering down environmental targets in a new long-term bonus plan for its chief executive, Georges Elhedery, who took over last year.
The climate campaign group ShareAction condemned the move, saying it was “yet another troubling signal around the bank’s commitment to addressing the climate crisis”.
Jeanne Martin, ShareAction’s co-director of corporate engagement, said: “It sends a counterproductive message to governments and companies, despite the multiplying financial risks of global heating and the heatwaves, floods and extreme weather it will bring.
skip past newsletter promotion
after newsletter promotion
“Investors will be watching closely how this backsliding move will translate into its disclosures and policies.”
HSBC said in a statement “We recognise the role the Net Zero Banking Alliance has played in developing guiding frameworks to help banks establish their initial target-setting approach.
“With this foundation in place, we have decided to withdraw from the NZBA as we work towards updating and implementing our own net zero transition plan.
“We remain resolutely focused on supporting our customers to finance their transition objectives and on making progress towards our net zero by 2050 ambition.”
A French probe into Elon Musk’s social media platform X deepened on Friday, when the Paris prosecutor’s office said it had enlisted police to investigate suspected abuse of algorithms and fraudulent data extraction by the company or its executives.
The move adds to the pressure on Musk, a former ally of US President Donald Trump who has accused European governments of attacking free speech and has also voiced support for some of the region’s far-right parties.
French police could conduct searches, wiretaps and surveillance against Musk and X executives, or summon them to testify. If they do not comply, a judge could issue an international arrest warrant.
X did not immediately respond to a request for comment.
Paris prosecutors launched a preliminary probe in January, after receiving complaints of alleged foreign interference by X from a lawmaker and a senior French official, Paris Prosecutor Laure Beccuau said in a statement.
On July 9, after preliminary findings provided by researchers and French public institutions, they asked police to investigate X “as both a legal entity and through individual persons”.
The alleged crimes are “organised interference with the functioning of an automated data processing system” and “organised fraudulent extraction of data from an automated data processing system”.
Paris prosecutors’ latest investigation of powerful tech figures may deepen a rift between Washington and European capitals over what sort of discourse is permitted online.
Pavel Durov, the Russian-born founder of the Telegram messaging app, is under judicial supervision in France after being arrested last year and placed under formal investigation for alleged organised crime on the app. He denies guilt.
Durov’s arrest, which Musk criticised, ignited a debate about free speech that has been taken up by senior Trump officials.
Musk has used X to personally support right-wing parties and causes in France, Germany and Britain. After months in lockstep with Trump, he recently broke with the president over his federal budget, and he is now launching his own political party.
Shares of Delta and other airlines cooled Friday after climbing yesterday.
Airline stocks, which soared yesterday after Delta’s latest results revived optimism about the sector, have come back to earth a bit today. Some analysts, however, expect tailwinds to continue.
The JETS ETF, which includes several airline shares, was recently down 2% after climbing more than 7% yesterday. Delta Air Lines (DAL), American Airlines (AAL), and United Airlines (UAL), all of which logged double-digit advances yesterday, were in the red today, though to less-dramatic degrees; Delta was off about 1%. (Read Investopedia’s full coverage of today’s trading here.)
Yesterday’s gains were fueled by optimism coming out of Delta, which issued a better-than-Wall-Street expected third-quarter revenue projection and reinstated guidance, the latter of which was read as bullish after an uncertain start to the year. (Delta also reported continued strength in the premium seats business and, separately, a move toward more AI adoption.)
The Delta news “gave the market a bright green light to pile back into the space and investors duly obliged,” Morgan Stanley analysts wrote Thursday.
Several analysts responded to Delta’s report with upbeat moves of their own. Morgan Stanley edged its target for the airline $2 higher to $90, well above the Visible Alpha consensus around $64 and higher than any of the targets tracked by the service. Bank of America lifted its target to $67 from $60.
Some wariness remains, however. Deutsche Bank maintained its $63 price target, characterizing the company’s tone during its report as “cautiously optimistic.”
Delta’s shares remain down about 6% for the year, though they’ve climbed off April lows.
Check Point® Software Technologies Ltd. (NASDAQ: CHKP), a pioneer and global leader of cyber security solutions, today announced it has been recognized as a Leader in The Forrester Wave™: Zero Trust Platforms, Q3 2025. The independent analyst report evaluated the 10 most significant Zero Trust platform providers and cited Check Point for delivering a unified, prevention-first security platform that covers network, cloud, and endpoint controls across hybrid environments.
Check Point received the highest possible scores (5 out of 5) in four critical criteria within the current offering category: centralized management and usability, least-privileged-access enforcement, segmentation and control, and deployment. The company also received 5/5 scores in the roadmap and supporting services and offerings criteria within the strategy category, which Check Point believes reinforces its strong vision and customer-centric approach.
“This recognition by Forrester affirms, for us, Check Point’s leadership in delivering consistent Zero Trust security that is comprehensive, intuitive, and built for the AI-driven, hyperconnected world,” said Nataly Kremer, Chief Product Officer at Check Point Software. “Our AI-powered Infinity Platform is purpose-built to help organizations secure users, assets, and data — wherever they reside — through centralized management, intelligent policy enforcement, and flexible deployment across cloud, on-prem, and hybrid environments.”
Check Point’s highlights from the report include:
Centralized Management
Least-Privileged Access Enforcement
Segmentation and control
Deployment
Roadmap
Supporting services and offerings
Forrester also noted that organizations looking for a centralized, easy-to-manage, and holistic network security platform for local networks should include Check Point on their shortlist.
For Check Point, this position as a leader reinforces the company’s commitment to a prevention-first strategy, helping enterprises proactively secure their infrastructure against modern threats while accelerating their Zero Trust adoption.Learn more on our blog and access a complimentary copy of The Forrester Wave™: Zero Trust Platforms, Q3 2025 here.
Forrester does not endorse any company, product, brand, or service included in its research publications and does not advise any person to select the products or services of any company or brand based on the ratings included in such publications. Information is based on the best available resources. Opinions reflect judgment at the time and are subject to change. For more information, read about Forrester’s objectivity here.
ISLAMABAD: On Thursday, President Asif Ali Zardari signed the Virtual Assets Regulatory Authority (Vara) Ordinance 2025, which establishes a new body to regulate virtual asset services in Pakistan. The ordinance aims to tackle money laundering and terrorist financing while ensuring the proper oversight of virtual asset transactions within the country.
The ordinance comes into immediate effect nationwide, with the authority’s head office located in Islamabad, although regional offices can be set up as needed. Vara will operate as a corporate entity, granting it the authority to acquire property, engage in contracts, make purchases and sales, and even file legal cases.
The new regulatory body will oversee the issuance, suspension, and revocation of licenses for virtual asset service providers. It will also regulate the virtual assets sector, enforce anti-money laundering and anti-terrorism financing measures, and have the power to investigate, impose fines, and take disciplinary actions.
The ordinance stipulates that a board will govern Vara, with the chairman and two members representing the Finance and Law Ministries. The board may include additional advisers. The chairman and non-official members will serve for a term of three years.
Furthermore, the ordinance mandates that no individual or entity may provide virtual asset services without a license from Vara. It also specifies that those offering such services without proper authorization may face fines.
The FDA has accepted the supplemental new drug application (sNDA) for decitabine and cedazuridine (Inqovi) plus venetoclax (Venclexta) in newly diagnosed patients with acute myeloid leukemia (AML) ineligible for intensive chemotherapy.
The phase 2b ASCERTAIN-V trial (NCT04975919) showed a 46.5% complete response (CR) rate and 15.5-month median overall survival (OS).
This is the first potential all-oral regimen in this setting, with no new safety concerns reported.
The FDA has accepted the sNDA of decitabine and cedazuridine plus venetoclax for the treatment of patients with newly diagnosed AML who are ineligible for intensive induction chemotherapy.1
The sNDA is supported by data from the phase 2b ASCERTAIN-V trial, which evaluated decitabine/cedazuridine plus venetoclax in 101 adults with newly diagnosed AML who were deemed unfit for intensive therapy. The trial achieved its primary end point with a CR rate of 46.5% (95% CI, 36.5%-56.7%) and showed a CR or CR with incomplete hematologic recovery (CR + CRi) rate of 63.4% (95% CI, 53.2%-72.7%).
The median OS was 15.5 months, and at 12 months, the median duration of response (DOR) had not yet been reached. Importantly, over 75% of patients who achieved a CR remained in remission at 1 year.
“If approved for patients with AML who are not eligible to undergo intensive induction chemotherapy, [decitabine/cedazuridine] in combination with venetoclax would offer the first all-oral alternative to current therapies,” said Harold Keer, MD, PhD, chief medical officer of Taiho Oncology, in a press release.
White blood cells in leukemia – stock.adobe.com
Patients in the ASCERTAIN-V trial received decitabine/cedazuridine orally on days 1 through 5 of a 28-day cycle along with daily oral venetoclax, reflecting a regimen that could be administered in an outpatient setting. The median follow-up in the study was 11.2 months. These results were first presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and further highlighted at the 2025 European Hematology Association (EHA) Congress.
The combination demonstrated a manageable safety profile with no new safety concerns. Grade 3 or higher adverse events (AEs) were reported in 98% of patients, consistent with expectations in this high-risk population. The most common AEs included febrile neutropenia (49.5%), anemia (38.6%), and neutropenia (35.6%). Early mortality was relatively low: deaths within 30 days of treatment initiation were observed in 3% of patients and 9.9% by 60 days, due to either AEs or disease progression. Importantly, no drug-drug interactions were observed between decitabine/cedazuridine and venetoclax.
Decitabine with cedazuridine is already FDA-approved for the treatment of myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). It is the only oral hypomethylating agent approved for adults with intermediate- and high-risk MDS, offering convenience over traditional intravenous options such as decitabine or azacitidine.
The FDA has granted the sNDA application a standard review with a Prescription Drug User Fee Act action date of February 25, 2026. If approved, the regimen will offer oncologists a novel, simplified option to manage newly diagnosed patients with AML who cannot tolerate intensive treatment. As more data emerge and real-world application expands, decitabine and cedazuridine plus venetoclax could redefine frontline care for a population long underserved by existing regimens.
REFERENCES:
1. Taiho Oncology and Taiho Pharmaceutical announce U.S. FDA acceptance of supplemental new drug application for INQOVI® in combination with venetoclax to treat patients with acute myeloid leukemia. News release. Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd. July 9, 2025. Accessed July 10, 2025. https://tinyurl.com/tc8svj6d
2. Roboz GJ, Zeidan AM, Mannis GN, et al. All-oral decitabine-cedazuridine (DEC-C) + venetoclax (VEN) in patients with newly diagnosed acute myeloid leukemia (AML) ineligible for induction chemotherapy: phase 1/2 clinical trial results. Presented at: European Hematology Association Congress; June 12-15, 2025; Milan, Italy. Abstract S135.
Four years after pre-surgery treatment with a novel combination of immune checkpoint inhibitors, nivolumab and relatlimab, 87% of patients with stage III melanoma remained alive, according to new results from a study led by researchers at The University of Texas MD Anderson Cancer Center.
Long-term follow-up data from this Phase II study, published today in the Journal of Clinical Oncology, demonstrate this combination provides long-term benefits to patients when given before and after surgery, and identified unique biomarkers associated with better outcomes and lower chance of recurrence.
Of the 30 patients enrolled on the study, 80% had no recurrence of their cancer after four years. For patients who had a significant response, called a major pathologic response, from treatment when evaluated at the time of surgery, even more remained recurrence free, at 95%.
“If immunotherapy eliminates most of the tumor before surgery, then we have sufficiently trained the immune system for an antitumor response, which minimizes the possibility of recurrence,” said corresponding author Elizabeth Burton, Ph.D., executive director of MD Anderson’s Strategic Research Initiative Development (STRIDE) program. “We are encouraged by these results showing the long-term benefit of this combination and approach for our patients and the opportunity it provides to learn as much as possible about what is driving this response to treatment.”
Stage III melanoma has a high risk of recurrence following surgery, highlighting an opportunity for the addition of pre-surgical, or neoadjuvant, immunotherapy to shrink the tumor and prime the immune system to guard against future recurrences.
Relatlimab is a LAG-3 inhibitor, an immune checkpoint inhibitor that was approved in 2022 in combination with nivolumab by the Food and Drug Administration (FDA) for patients with advanced melanoma based on the Phase II/III RELATIVITY-047 clinical trial, led by Hussein Tawbi, MD, PhD, professor of Melanoma Medical Oncology.
In this Phase II trial, led by Rodabe Amaria, MD, professor of Melanoma Medical Oncology, researchers were first to evaluate this combination in the neoadjuvant setting for earlier stage disease. Initial findings reported this combination was safe and effective in that setting.
Because of the strong association to outcomes with major pathologic response, researchers evaluated biomarkers to better understand the factors associated with treatment response.
They found that patients who had high pre-treatment levels of one biomarker, called TIGIT, or low levels of another biomarker, called B7-H3, had the best chance of remaining recurrence-free, highlighting the potential to use these markers to predict patient responses in the future.
“This study highlights the tremendous impact integrating excellent multi-disciplinary care with team science can have on improving patient outcomes while advancing science and innovation. The neoadjuvant treatment approach allows us to quickly evaluate the clinical impact of a treatment and serves as a springboard for biomarker research.” Burton said. “This is a good starting point for where researchers can look in terms of mechanisms of resistance that could be potential therapeutic targets in the future.”
Going forward, the authors are collaborating with researchers at MD Anderson’s James P. Allison Institute to validate these biomarkers and to use spatial profiling to further understand where they are located and how they can impact the tumor microenvironment.