Q4 2025: 10 FDA Decisions to Watch in the Realm of Oncology

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As Q4 begins, the oncology community is closely watching the FDA for several key regulatory decisions. With potential approvals spanning a range of therapeutic areas, the next few months could introduce new treatment options and reshape current standards of care.

Here is OncLive’s curated list of 10 FDA decisions to watch this quarter.

#1: Adjuvant Cemiplimab-rwlc

Drug Indication: High-Risk Cutaneous Squamous Cell Carcinoma
Projected Action Date: October

On May 31,2025, Regeneron Pharmaceuticals, Inc. announced that regulatory applications were submitted for cemiplimab (Libtayo) as adjuvant treatment in patients with cutaneous squamous cell carcinoma (CSCC) based on findings from the phase 3 C-POST trial (NCT03969004).1 At a median follow-up of 24 months (range, 2-64), cemiplimab led to a 68% reduction in the risk of disease recurrence or death vs placebo (HR, 0.32; 95% CI, 0.20-0.51; P < .0001); the median event-free survival (EFS) was not reached with cemiplimab vs 49 months with placebo. The immunotherapy also led to an 80% reduction in the risk of locoregional recurrence (HR, 0.20; 95% CI, 0.09-0.40) and a 65% reduction in the risk of distant recurrence (HR, 0.35; 95% CI, 0.17-0.72).

According to Regeneron, cemiplimab could become a new standard of care (SOC) in the adjuvant setting for high-risk CSCC, addressing a critical unmet need for systemic therapies to prevent relapse.

#2: Lurbinectedin Plus Atezolizumab – JUST APPROVED!

Drug Indication: First-line Maintenance ES-SCLC
Projected Action Date: October 7, 2025

On October 2, 2025, the FDA approved lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqis (Tecentriq Hybreza) for maintenance treatment in adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after frontline induction therapy with atezolizumab or atezolizumab and hyaluronidase, carboplatin, and etoposide.2 Data from the phase 3 IMforte trial (NCT05091567) indicated that treatment with the doublet (n = 242) led to statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) vs atezolizumab alone (n = 241). The median PFS in the respective arms was 5.4 months vs 2.1 months, and the median OS in the respective arms was 13.2 months vs 10.6 months.

According to Jazz Pharmaceuticals, the approval offers a new maintenance option for ES-SCLC, improving PFS and OS, and providing a proactive approach in a disease with rapid relapse.3 “The study of lurbinectedin in combination with atezolizumab vs atezolizumab alone is a practice-changing study,” Joshua K. Sabari, MD, of NYU Grossman School of Medicine and Perlmutter Cancer Center, said in an interview with OncLive®.4 “It’s important to select patients who are fit, have a good performance status, and whose hematologic parameters meet the utilization [criteria for] lurbinectedin and atezolizumab, but it is something I will be using in my clinical practice. Patients who are not eligible for maintenance trials should be offered lurbinectedin plus atezolizumab in the maintenance setting for ES-SCLC.”

#3: Dasatinib Amorphous

Drug Indication: CML/ALL
Projected Action Date: October 7, 2025

On February 13, 2024, Xspray Pharma announced that the regulatory agency accepted for filing the resubmission of a new drug application (NDA) for Dasynoc (XS004-dasatinib) for use in patients with chronic myeloid leukemia (CML) and acute lymphoblastic leukemia.5 Based on its optimized formulation, Dasynoc maintains efficacy at lower doses with reduced variability and displays stable absorption even with concomitant proton pump inhibitor use, supported by retrospective registry and crossover study data.

This was followed by another complete response letter requesting additional information pertaining to labeling comprehension and the pre-approval inspection at the third party’s manufacturing site but did not raise concerns regarding clinical efficacy or stability.6 In April 2025, the application was resubmitted and a Prescription Drug User Fee Act date was set for October 7, 5025.7 According to Xspray Pharma, the resubmission and upcoming PDUFA date bring Dasynoc closer to becoming a new, potentially more flexible treatment option for patients.6

#4: Belantamab Mafodotin-blmf Regimens

Drug Indication: Second-Line R/R Multiple Myeloma
Projected Action Date: October 23, 2025

On November 25, 2024, GSK plc announced the regulatory agency accepted a biologics license application (BLA) seeking approval of belantamab mafodotin-blmf (Blenrep) for use in combination with bortezomib (Velcade) and dexamethasone (BVd) and with pomalidomide (Pomalyst) and dexamethasone (BPd) for patients with multiple myeloma who have previously received at least 1 line of therapy.8 Based on data from the phase 3 DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) trials, both belantamab mafodotin–based combinations significantly improved PFS vs standard-of-care triplet regimens. Specifically, DREAMM-7 data showed a median PFS of 36.6 months with BVd vs 13.4 months with DVd, and DREAMM-8 findings demonstrated a median PFS that was not reached with BPd vs 12.7 months with PVd.

On July 17, 2025, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5 to 3 and 7 to 1 against the risk:benefit profile of the proposed dosage of the agent in these respective regimens.9 A few days later, GSK plc announced that the regulatory agency extended the review period to allow for more time to examine additional information provided in support of the application.9 According to GSK, these submissions could expand treatment options for relapsed/refractory multiple myeloma and provide meaningful efficacy in community-based settings.8

#5: Revumenib

Drug Indication: NPM1-Mutated R/R Acute Myeloid Leukemia
Projected Action Date: October 25, 2025

On June 24, 2025, Syndax Pharmaceuticals announced the FDA granted priority review to the sNDA seeking approval of revumenib (Revuforj) for the treatment of patients with relapsed or refractory NPM1-mutant acute myeloid leukemia (AML).11 Based on findings from the phase 1/2 AUGMENT-101 trial (NCT04065399), the agent elicited a complete remission (CR) + CR with partial hematologic recovery (CRh) rate of 26.0% (95% CI, 16.6%-37.2%) and an overall response rate (ORR) of 48.1% in this population (n = 77).12 The median time to first CR + CRh was 2.8 months (range, 0.9-8.8) and the median duration of CR + CRh was 4.7 months (95% CI, 2.1-8.2).

According to Syndax, this review builds on revumenib’s initial approval for KMT2A-rearranged acute leukemia and could expand the first-in-class menin inhibitor’s use to a broader AML population.11

#6: Sevabertinib (BAY 2927088)

Drug Indication: HER2-Mutated NSCLC
Projected Action Date: November

On May 28, 2025, Bayer announced that the FDA granted priority review to the NDA for sevabertinib (BAY 2927088) for use in adult patients with advanced non–small cell lung cancer (NSCLC) harboring HER2 mutations who have received prior systemic treatment.13 Based on findings from the phase 1/2 SOHO-01 trial (NCT05099172), the agent elicited an ORR of 70.5% (95% CI, 54.8%-83.2%) in cohort D (n = 44), which included those who were naive to HER2-targeted therapy; the ORR was 35.3% (95% CI, 19.7%-53.5%) in cohort E (n = 34), which was comprised of patients with prior exposure to HER2-targeted antibody-drug conjugates. The disease control rates in the respective cohorts were 81.8% and 52.9%. The median duration of response in the respective arms was 8.7 months (95% CI, 4.5-not estimable [NE]) and 9.5 months (95% CI, 4.1-NE).

According to Bayer, this could provide a new treatment option for previously treated patients with HER2-mutant NSCLC. Further evaluation of the agent as a first-line option continues in the phase 3 SOHO-02 trial (NCT06452277).

#7: Ziftomenib (KO-539)

Drug Indication NPM1-Mutated R/R AML
Projected Action Date: November 30, 2025

On June 1, 2025, Kura Oncology announced that the FDA granted priority review to the NDA seeking approval of ziftomenib (KO-539) for use in adult patients with relapsed/refractory AML harboring an NPM1 mutation.14 Based on findings from the phase 1/2 KOMET-001 trial (NCT04067336), the agent met its primary end point of CR plus CRh and was well tolerated with limited myelosuppression.

According to Kura Oncology, this NDA acceptance represents a critical step toward providing a new treatment option for patients with this aggressive AML subset with limited therapies.

#8: Epcoritamab-bysp Plus R2

Drug Indication: Second-Line R/R Follicular Lymphoma
Projected Action Date: November 30, 2025

On August 7, 2025, Genmab announced that the FDA accepted for priority review a supplemental BLA (sBLA) seeking approval of subcutaneous epcoritamab-bysp (Epkinly) plus rituximab (Rituxan) and lenalidomide (Revlimid; R2) for use in adult patients with relapsed/refractory follicular lymphoma who have received at least 1 prior systemic therapy.15 Based on positive topline findings from the first interim analysis of the phase 3 EPCORE FL-1 trial (NCT05409066), the regimen significantly improved ORR (95.7%; P < .0001) and PFS (HR, 0.21; P < .0001) in the intention-to-treat population. The safety profile was consistent with known profiles of the individual regimens.

According to Genmab A/S, if approved, epcoritamab plus R2 would be the first bispecific antibody combination regimen available for second-line use in patients with relapsed or refractory follicular lymphoma.

#9: Lisocabtagene Maraleucel

Drug Indication: Second-Line R/R MZL
Projected Action Date: December 5, 2025

On August 4, 2025, Bristol Myers Squibb (BMS) announced that the regulatory agency granted priority review to an sBLA for lisocabtagene maraleucel (liso-cel; Breyanzi) for use in adult patients with relapsed/refractory marginal zone lymphoma (MZL) who have received 2 or more prior lines of systemic therapy.16 Based on findings from the MZL cohort of the phase 2 TRANSCEND FL trial (NCT04245839), evaluable patients experienced an ORR of 95.5% (95% CI, 87.3%-99.1%), which included a CR rate of 62.1%.17 Moreover, 24-month DOR, PFS, and OS rates were 88.6%, 85.7%, and 90.4%, respectively.

According to BMS, liso-cel possesses the potential to be the first and only CAR T-cell therapy approved for this disease, addressing a high unmet need.16

#10: Perioperative Durvalumab

Drug Indication: Resectable Extensive-Stage Locally Advanced Gastric or Gastroesophageal Junction Cancer
Projected Action Date: Q4 2025

On July 28, 2025, AstraZeneca announced that the regulatory agency granted priority review to an sBLA seeking approval of perioperative durvalumab (Imfinzi) for the treatment of patients with resectable, early-stage, locally advanced gastric and gastroesophageal junction (GEJ) cancers.18 Based on data from the phase 3 MATTERHORN trial (NCT04592913), patients treated with perioperative durvalumab plus FLOT (fluorouracil, leucovorin, oxaliplatin, docetaxel) experienced a 29% reduction in the risk of disease progression, recurrence, or death vs FLOT alone; the median event-free survival was not reached (NR; 95% CI, 40.7-NR) in the durvalumab arm vs 32.8 months (95% CI, 27.9-NR) in the FLOT-alone arm.19

According to AstraZeneca, if approved, this will be the first and only perioperative immunotherapy-based regimen in this setting.18

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References

  1. Libtayo (cemiplimab) phase 3 data in the adjuvant treatment of post-surgical high-risk cutaneous squamous cell carcinoma (CSCC) have potential to be practice-changing. News release. Regeneron Pharmaceuticals, Inc. May 31, 2025. Accessed October 3, 2025. https://newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-phase-3-data-adjuvant-treatment-post
  2. FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer. FDA. October 2, 2025. Accessed October 3, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive
  3. FDA Approves Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) combination as first-line maintenance therapy for extensive-stage small cell lung cancer. News release. Jazz Pharmaceuticals, plc. October 2, 2025. Accessed October 3, 2025. https://investor.jazzpharma.com/news-releases/news-release-details/fda-approves-zepzelcar-lurbinectedin-and-atezolizumab-tecentriqr
  4. Sabari JK. Dr Sabari on the FDA approval of maintenance lurbinectedin plus atezolizumab for ES-SCLC. OncLive.com. October 2, 2025. Accessed October 3, 2025. https://www.onclive.com/view/dr-sabari-on-the-fda-approval-of-maintenance-lurbinectedin-plus-atezolizumab-for-es-sclc
  5. FDA Accepts Xspray Pharma’s NDA resubmission for Dasynoc – PDUFA date set to 31 July 2024. News Release. Xspray Pharma AB. February 12, 2024. Accessed October 3, 2025. https://xspraypharma.com/modular_finance_pressmeddelande/fda-accepts-xpray-pharmas-nda-resubmission-for-dasynoc-pdufa-date-set-to-31-july/
  6. Xspray Pharma shares new information on Dasynoc, a novel CML treatment in development. News release. Xspray Pharma AB. July 26, 2024. Accessed October 3, 2025. https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-shares-new-information-on-dasynoc-a-novel-cml-treatment-in-development/
  7. FDA sets PDUFA-date for Xspray Pharma’s resubmitted application for Dasynoc. May 14, 2025. Accessed October 3, 2025. https://storage.mfn.se/5b60bfd0-bbac-47aa-bb56-ffae6bed3454/fda-sets-pdufa-date-for-xspray-pharmas-re-submitted-application-for-dasynoc-r.pdf
  8. Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma. News release. GSK. November 25, 2024. Accessed October 3, 2025. https://www.gsk.com/en-gb/media/press-releases/blenrep-combinations-accepted-for-review-by-the-us-fda-for-the-treatment-of-relapsedrefractory-multiple-myeloma/
  9. July 17, 2025, Meeting of the Oncologic Drugs Advisory Committee (ODAC). FDA. Accessed October 3, 2025. https://www.youtube.com/live/CLhBI3UXWyg
  10. GSK announces extension of US Food and Drug Administration review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma. News release. GSK. July 23, 2025. Accessed October 3, 2025. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-extension-of-us-food-and-drug-administration-review-period-for-blenrep-belantamab-mafodotin-blmf-in-relapsedrefractory-multiple-myeloma/
  11. Syndax announces FDA priority review of sNDA for Revuforj (revumenib) in relapsed or refractory mNPM1 acute myeloid leukemia. News release. Syndax Pharmaceuticals. June 24, 2025. Accessed October 3, 2025. https://ir.syndax.com/news-releases/news-release-details/syndax-announces-fda-priority-review-snda-revuforjr-revumenib
  12. Arellano ML, Thirman MJ, DiPersio JF, et al. Revumenib for patients with relapsed or refractory (R/R) Nucleophosmin 1–mutated (NPM1m) acute myeloid leukemia (AML): updated results from the phase 2 AUGMENT-101 study. Presented at: 2025 EHA Congress; June 12-15, 2025; Milan, Italy. https://cms.syndax.com/wp-content/uploads/2025/04/Arellano_2025-EHA_AUGMENT-101-NPM1m-Ph2_Poster_Final.pdf
  13. Sevabertinib (BAY 2927088) granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer. News release. Bayer. May 28, 2025. Accessed October 3, 2025. https://www.bayer.com/media/en-us/sevabertinib-bay-2927088-granted-fda-priority-review-for-the-treatment-of-patients-with-her2-mutant-non-small-cell-lung-cancer/
  14. Kura Oncology and Kyowa Kirin announce FDA acceptance and priority review of new drug application for ziftomenib in adults with relapsed or refractory NPM1-mutant AML. News release. Kura Oncology. June 1, 2025. Accessed October 3, 2025. https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-announce-fda-acceptance-and
  15. Genmab announces phase 3 EPCORE FL-1 clinical trial met dual primary endpoints in patients with relapsed/refractory (R/R) follicular lymphoma (FL). News release. Genmab A/S. August 7, 2025. Accessed October 3, 2025. https://ir.genmab.com/news-releases/news-release-details/genmab-announces-phase-3-epcorer-fl-1-clinical-trial-met-dual
  16. Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) accepted for priority review by U.S. Food and Drug Administration (FDA) in fifth cancer type for relapsed or refractory marginal zone lymphoma (MZL). News release. Bristol Myers Squibb. August 4, 2025. Accessed October 3, 2025. https://news.bms.com/news/details/2025/Bristol-Myers-Squibbs-Application-for-Breyanzi-lisocabtagene-maraleucel-Accepted-for-Priority-Review-by-U-S–Food-and-Drug-Administration-FDA-in-Fifth-Cancer-Type-for-Relapsed-or-Refractory-Marginal-Zone-Lymphoma-MZL/default.aspx
  17. Bristol Myers Squibb presents first data from the marginal zone lymphoma cohort of the Transcend FL trial demonstrating deep and durable responses with Breyanzi (lisocabtagene maraleucel). News release. Bristol Myers Squibb. June 16, 2025. Accessed October 3, 2025. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-First-Data-from-the-Marginal-Zone-Lymphoma-Cohort-of-the-Transcend-FL-Trial-Demonstrating-Deep-and-Durable-Responses-with-Breyanzi-lisocabtagene-maraleucel/default.aspx
  18. Imfinzi granted priority review and breakthrough therapy designation in the US for patients with resectable early-stage gastric and gastroesophageal junction cancers. News release. AstraZeneca. July 28, 2025. Accessed October 3, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-granted-priority-review-and-breakthrough-therapy-designation-us-patients-with-resectable-early-stage-gastric-gastroesophageal-junction-cancers.html
  19. Janjigian Y, Al-Batran S-E, Wainberg Z, et al. Event-free survival (EFS) in MATTERHORN: a randomized, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel chemotherapy (FLOT) in resectable gastric/gastroesophageal junction cancer (GC/GEJC). J Clin Oncol. 2025;43(suppl 17):LBA5. doi:10.1200/JCO.2025.43.17_suppl.LBA5

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