Q3 2025: 10 FDA Decisions to Watch in the Realm of Oncology

Q3 2025: FDA Decisions to Watch

As the second quarter of 2025 closes, the pace of oncology innovation shows no signs of slowing. Recent FDA approvals have reinforced the shift toward more targeted, immunologically driven, and personalized therapies across a broad spectrum of cancers.

Nivolumab (Opdivo) plus ipilimumab delivered a first-ever dual checkpoint inhibitor regimen with meaningful efficacy in hepatocellular carcinoma, including a 36% response rate and a median duration of response (DOR) over 30 months. The full approval of larotrectinib (Vitrakvi) solidified its role in treating NTRK fusion–positive cancers, while telisotuzumab vedotin-tllv (Emrelis) became the first approved therapy targeting c-MET overexpression in non–small cell lung cancer (NSCLC). Groundbreaking approvals for penpulimab-kcqx in nasopharyngeal carcinoma, avutometinib/defactinib (Avmapki Fakzynja Co-pack) in low-grade serous ovarian cancer, belzutifan (Welireg) in rare tumors, and retifanlimab-dlwr (Zynz) in squamous anal cancer all signal a push toward more precision-guided, histology-specific treatment strategies.

Against this backdrop of rapid progress, Q3 is expected to bring a new wave of FDA decisions that could reshape standards of care across solid tumors, hematologic malignancies, and rare cancers.

Below are 10 key regulatory actions to watch in the coming months:

#1: Sunvozertinib (DZD9008)

Drug Indication: EGFR Exon 20+ Advanced NSCLC
Projected Action Date: July 7, 2025

On November 8, 2024, Dizal submitted a new drug application (NDA) to the FDA seeking approval of sunvozertinib (DZD9008) for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations whose disease progressed after platinum-based chemotherapy.1 Based on phase 2 WU-KONG1 trial (NCT03974022) data, the 300-mg dose showed a confirmed ORR of 44.9% and a 9-month DOR rate of 57%. Safety findings were manageable, with mostly low-grade adverse events and few treatment discontinuations.

Sunvozertinib was previously approved in China for the same indication. According to Dizal, this NDA marks a major milestone for a potential first-in-class oral therapy addressing a difficult-to-treat NSCLC subset.

#2: Linvoseltamab

Drug Indication: Relapsed/Refractory Multiple Myeloma
Projected Action Date: July 10, 2025

On March 28, 2025, Regeneron announced the FDA accepted its resubmitted biologics license application (BLA) for linvoseltamab to treat patients with relapsed/refractory multiple myeloma in patients with at least 4 prior lines of therapy or who received 3 prior lines of therapy and are refractory to their last line of therapy.2 Based on data from the phase 1/2 LINKER-MM1 trial (NCT03761108), the 200-mg dose elicited a 71% overall response rate (ORR), with 50% achieving a complete response or better.

The BLA was resubmitted following resolution of prior manufacturing issues cited in a 2024 complete response letter (CRL). The FDA set a new target action date of July 10, 2025. According to Regeneron, linvoseltamab could offer a meaningful new option for patients with few remaining treatments.

#3: Glofitamab Plus Gemcitabine/Oxaliplatin

Drug Indication: Relapsed/Refractory DLBCL
Projected Action Date: July 20, 2025

On December 5, 2024, Genentech announced the FDA accepted its supplemental BLA for glofitamab-gxbm (Columvi) in combination with gemcitabine/oxaliplatin (GemOx) for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant.3 Based on the phase 3 STARGLO trial (NCT04408638), the regimen (n = 183) significantly improved overall survival (OS) compared with rituximab (Rituxan) plus GemOx (n = 91; HR, 0.59; 95% CI, 0.40-0.89; P = .011).

On May 20, 2025, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 1 against the applicability of the trial’s results to the US population with relapsed/refractory DLBCL, citing concerns about regional differences in efficacy and limited US enrollment.4 According to Genentech, this combination could offer a new treatment option for patients with limited alternatives and a high risk of disease progression.

#4: Vuslimogene Oderparepvec (RP1) Plus Nivolumab

Drug Indication: Advanced Melanoma
Projected Action Date: July 22, 2025

On April 1, 2025, Replimune announced the FDA accepted and granted priority review to its BLA for vusolimogene oderparepvec (RP1) plus nivolumab for the treatment of patients with advanced melanoma previously treated with a PD-1 inhibitor.5 Based on phase 2 data from the IGNYTE trial (NCT03767348), the combination showed a 33.6% ORR, with durable responses and a manageable safety profile.

The confirmatory phase 3 IGYNTE-3 trial (NCT06264180) has been initiated to assess the combination in patients with advanced melanoma who have progressed on anti–PD-1 and anti–CTLA-4 therapies or are ineligible for treatment with an anti–CTLA-4 agent. The FDA set a target action date of July 22, 2025, and does not plan to hold an advisory committee meeting. The combination also received breakthrough therapy designation in late 2024. According to Replimune, this therapy could address a critical unmet need for patients with limited remaining options.

#5: Belantamab Mafodotin Plus BVd and BPd

Drug Indication: Relapsed/Refractory Multiple Myeloma
Projected Action Date: July 23, 2025

On April 2, 2025, GSK announced the FDA accepted a BLA seeking approval of belantamab mafodotin (Blenrep) in combination with either bortezomib (Velcade) and dexamethasone (BVd) or pomalidomide (Pomalyst) and dexamethasone (PVd) for patients with multiple myeloma who have received at least 1 prior line of therapy.6 Based on data from the phase 3 DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) trials, both combinations significantly improved progression-free survival (PFS) over standard regimens.

The FDA set a target action date of July 23, 2025, under the Prescription Drug User Fee Act. According to GSK, these regimens may expand treatment options with meaningful efficacy and community-based use.

#6: Odronextamab

Drug Indication: Relapsed/Refractory Follicular Lymphoma
Projected Action Date: July 30, 2025

On February 26, 2025, Regeneron announced FDA acceptance of its resubmitted BLA for odronextamab (Ordspono) to treat patients with relapsed/refractory follicular lymphoma after 2 or more lines of systemic therapy.7 Based on data from the ELM-1 (NCT02290951) and ELM-2 (NCT03888105) trials, the agent showed an ORR of 80% and a CR rate of 74%.

The resubmission follows a March 2024 CRL that cited issues with confirmatory trial enrollment but raised no concerns about safety or efficacy. The regulatory agency assigned a new PDUFA date of July 30, 2025. According to Regeneron, odronextamab could offer a meaningful option for patients with limited treatment choices.

#7: Dordaviprone (ONC201)

Drug Indication: Recurrent H3K27M+ Diffuse Glioma
Projected Action Date: August 18, 2025

On February 18, 2025, Chimerix announced FDA acceptance and priority review of its NDA seeking accelerated approval of dordaviprone (ONC201) for use in patients with recurrent H3K27M-mutant diffuse glioma.8 Based on pooled data from a compassionate use program, a phase 1 trial (NCT03416530), and 3 phase 2 trials (NCT03295396; NCT02525692; NCT03134131), the drug showed an ORR of 20% and a disease control rate of 40%, with a median duration of response of 11.2 months.

A PDUFA date of August 18, 2025, has been set, and the regulatory agency granted the therapy rare pediatric disease designation. Chimerix has also applied for a priority review voucher as part of the submission. According to the company, dordaviprone could become the first targeted therapy for this aggressive pediatric brain cancer with limited treatment options.

#8: Leuprolide Mesylate

Drug Indication: Advanced Prostate Cancer
Projected Action Date: August 29, 2025

On January 13, 2025, Foresee Pharmaceuticals announced the FDA issued a Day-74 letter setting a PDUFA date of August 29, 2025, for the 3-month, 21-mg formulation of leuprolide mesylate (Camcevi) to treat advanced prostate cancer.9 Based on a phase 3 trial (NCT03261999), 97.9% of patients maintained testosterone suppression below castration levels through day 168. No testosterone surge was observed after the second injection, supporting the treatment’s sustained effect.

This formulation complements the already approved 6-month version, expanding Foresee’s ready-to-use injectable options. According to the company, the new version could offer more flexibility in hormone suppression regimens for prostate cancer care.

#9: Subcutaneous Pembrolizumab

Drug Indication: Solid Tumors
Projected Action Date: September 23, 2025

On March 27, 2025, Merck announced FDA acceptance of a BLA for subcutaneous pembrolizumab (pembrolizumab with berahyaluronidase alfa) across all approved solid tumor indications based on data from the phase 3 MK-3475A-D77 trial (NCT05722015).10 The subcutaneous formulation demonstrated noninferior pharmacokinetics and comparable efficacy and safety to intravenous (IV) pembrolizumab when given with chemotherapy for metastatic non–small cell lung cancer.

The median injection time was 2 minutes, significantly reducing chair and treatment room time for patients and the workload of healthcare providers. The trial also showed similar response rates and PFS between the subcutaneous and IV groups. According to Merck, if approved, this could be the first subcutaneous checkpoint inhibitor, streamlining cancer care delivery without compromising outcomes.

#10: Zongertinib

Drug Indication: HER2-Mutant NSCLC
Projected Action Date: Q3

On February 19, 2025, Boehringer Ingelheim announced the FDA granted priority review to its NDA for zongertinib (BI 1810631) to treat patients with HER2-mutant unresectable or metastatic NSCLC after prior systemic therapy.11 Based on phase 1 Beamion LUNG-1 (NCT04886804) data, zongertinib demonstrated an ORR of 71%, with 6-month PFS and DOR rates of 69% and 73%, respectively.

The targeted HER2 inhibitor also showed a favorable safety profile, with low rates of serious adverse events and no cases of treatment-related interstitial lung disease. A PDUFA decision is expected in Q3 2025. According to Boehringer Ingelheim, zongertinib could offer a first-in-class option for a patient group with limited treatment alternatives.

References

1. U.S. FDA granted priority review to Dizal’s sunvozertinib new drug application. News release. Dizal. January 7, 2025. Accessed June 24, 2025. https://www.dizalpharma.com/news/detail?id=84&search=&currentPage=1
2. Linvoseltamab BLA accepted for FDA review for the treatment of relapsed/refractory multiple myeloma.News release. Regeneron. February 11, 2025. Accessed June 24, 2025. https://investor.regeneron.com/news-releases/news-release-details/linvoseltamab-bla-accepted-fda-review-treatment
3. FDA accepts supplemental biologics license application for Genentech’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma. News release. Genentech. December 4, 2024. Accessed June 24, 2025. https://www.gene.com/media/press-releases/15045/2024-12-04/fda-accepts-supplemental-biologics-licen
4. May 20, 2025, Meeting of the Oncologic Drugs Advisory Committee (ODAC). FDA. https://www.youtube.com/live/iSGFdhMgh1E. Accessed June 24, 2025.
5. Replimune announces biologics license application acceptance and priority review for RP1 for the treatment of advanced melanoma.News release. Replimune. January 21, 2025. Accessed June 24, 2025. https://ir.replimune.com/news-releases/news-release-details/replimune-announces-biologics-license-application-acceptance-and
6. Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma. News release. GSK. November 25, 2024. Accessed June 24, 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/
7. Odrenextamab BLA accepted for FDA review for the treatment of relapsed/refractory follicular lymphoma. News Release. Regeneron. February 26, 2025. Accessed June 24, 2025. https://investor.regeneron.com/news-releases/news-release-details/odronextamab-bla-accepted-fda-review-treatment
8. Chimerix announces FDA acceptance and priority review of new drug application for dordaviprone as treatment for recurrent H3 K28M-mutant diffuse glioma. News Release. Chimerix. February 18, 2025. Accessed June 24, 2025. https://ir.chimerix.com/news-releases/news-release-details/chimerix-announces-fda-acceptance-and-priority-review-new-drug
9. Foresee Pharmaceuticals announces the PDUFA goal date for the 3-month version of CAMCEVI is August 29, 2025. News release. Foresee Pharmaceuticals. January 13, 2025. Accessed June 24, 2025. https://www.foreseepharma.com/en/news/category/press_releases/tbc?page=1
10. FDA accepts MSD’s sBLA for SC pembrolizumab; decision expected September 2025. Pearce IP. May 27, 2025. Accessed June 24, 2025. https://www.pearceip.law/2025/03/27/fda-accepts-msd-bla-for-sc-pembrolizumab-decision-expected-september-2025/
11. Boehringer’s zongertinib receives Priority Review from U.S. FDA for the treatment of HER2 (ERBB2)-mutant advanced non-small cell lung cancer. GlobeNewswire News Room. February 19, 2025. Accessed June 24, 2025. https://www.boehringer-ingelheim.com/us/zongertinib-granted-priority-review-us-fda