This week’s oncology update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.
In this newsletter
Dive deeper
💊 Zidesamtinib NDA accepted, PDUFA set [1] [US • 19 Nov 2025]
https://investors.nuvalent.com/2025-11-19-Nuvalent-Announces-FDA-Acceptance-of-New-Drug-Application-for-Zidesamtinib-for-the-Treatment-of-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC
Context: NDA supported by ARROS-1 Phase 1/2 in TKI-pretreated ROS1-positive NSCLC.
Key point: FDA accepted filing for adult ROS1-positive NSCLC after at least 1 prior ROS1 TKI, PDUFA 18 Sep 2026.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
✅ HYRNUO (sevabertinib) accelerated approval in HER2-mut NSCLC [2] [US • 20 Nov 2025]
https://www.bayer.com/en/us/news-stories/hyrnuo
Context: Based on ongoing Phase I/II SOHO-01; Breakthrough Therapy in 2024.
Key point: FDA approved oral TKI for previously treated HER2 TKD-mutated non-squamous NSCLC, ORR/DoR surrogate basis.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
📬 Zipalertinib rolling NDA initiated (EGFR ex20ins) [3] [US • 20 Nov 2025]
https://www.taihooncology.com/us/news/taiho-oncology-taiho-pharmaceutical-and-cullinan-therapeutics-initiate-rolling-submission-of-new-drug-application-to-us-food-and-drug-administration-for-zipalertinib-for-treatment-of-locally-advanced-or-metastatic-non-small-cell-lung-cancer-with-egfr-e/
Context: REZILIENT1 Phase 1/2 primary efficacy data; BTD since 2021.
Key point: Companies started rolling NDA seeking accelerated approval post-platinum; completion anticipated 1Q 2026 per release.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.
🧬 IMDELLTRA full FDA approval in ES-SCLC post-platinum [4] [US • 19 Nov 2025]
https://www.amgen.com/newsroom/press-releases/2025/11/fda-grants-full-approval-to-amgens-imdelltra-in-extensive-stage-small-cell-lung-cancer
Context: DeLLphi-304 Phase 3 met primary OS endpoint.
Key point: Converted from accelerated to full approval with 40% reduction in risk of death vs chemo, median OS 13.6 vs 8.3 months.
Implication: Clinical topline/efficacy: May influence prescriber choice and payer reviews pending full data.
📦 Gedatolisib NDA completed under RTOR (HR+/HER2-, PIK3CA WT) [5] [US • 17 Nov 2025]
https://www.biospace.com/press-releases/celcuity-announces-completion-of-submission-of-its-new-drug-application-to-the-u-s-fda-for-gedatolisib-in-hr-her2-pik3ca-wild-type-advanced-breast-cancer
Context: Submission based on VIKTORIA-1 PIK3CA wild-type cohort.
Key point: Celcuity finished NDA for pan-PI3K/mTOR inhibitor combinations; RTOR pathway.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
⚡ Fast Track for DPTX3186 in gastric cancer [6] [US • 17 Nov 2025]
https://dewpointx.com/fda-grants-fast-track-designation-to-dewpoint-therapeutics-dptx3186-for-the-treatment-of-gastric-cancer/
Context: IND opened, Orphan Drug Designation granted; Phase 1a/2a initiation planned this year.
Key point: FDA Fast Track for first-in-class condensate modulator of Wnt/β-catenin in gastric cancer.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.
🧪 Pelareorep pivotal Phase 3 design aligned with FDA in 1L mPDAC [7]
https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer/
Context: Type C meeting; trial compares GnP ± pelareorep ± CPI vs GnP.
Key point: Primary endpoint OS, interim analysis possible; CPI choice flexible for triple-combo arm.
Implication: Clinical topline/efficacy: May influence prescriber choice and payer reviews pending full data.
🇯🇵 Braftovi combo wins first-line CRC approval in Japan [8] [Japan • 20 Nov 2025]
https://www.ono-pharma.com/en/news/20251120.html
Context: BREAKWATER Phase 3 in BRAFV600E-mutant CRC, first-line setting.
Key point: Supplemental approval for encorafenib + cetuximab + FOLFOX, improved ORR and PFS vs chemo.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
🇪🇺 Libtayo approved in EU as first adjuvant immunotherapy for CSCC [9] [EU • 19 Nov 2025]
https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-approved-european-union-first-and-only
Context: C-POST Phase 3 adjuvant CSCC.
Key point: EC approval based on 68% reduction in recurrence or death vs placebo.
Implication: Access programs: May expand screening, initiation, and follow-up at scale.
💉 KEYTRUDA SC approved across EU adult indications [10] [EU • 19 Nov 2025]
https://www.businesswire.com/news/home/20251119081276/en/European-Commission-Approves-Subcutaneous-Administration-of-KEYTRUDA-pembrolizumab-for-All-Adult-Indications-Approved-in-the-European-Union
Context: 3475A-D77 showed comparable exposure and consistent efficacy descriptors vs IV with chemo in 1L metastatic NSCLC.
Key point: First subcutaneous checkpoint inhibitor in Europe, admin in 1–2 minutes by HCP, every 3 or 6 weeks.
Implication: DTC/telehealth: Could streamline initiation and adherence via remote prescribing and logistics.
Why It Matters
- The US lung-cancer landscape shifted with a new HER2-mut NSCLC TKI and durable DLL3-targeted immunotherapy now fully approved.
- Targeted options advance across niches, from ROS1 resistance to EGFR exon 20 insertions, potentially broadening precision-oncology reach.
- EU access innovations include the first SC PD-1 and first adjuvant immunotherapy for high-risk CSCC, improving clinic flow and earlier intervention.
- Japan’s first-line encorafenib-based regimen may set a new bar in BRAFV600E-mutant CRC.
- Novel modalities, including condensate modulators and oncolytic immunotherapy, progress into registrational pathways.
🚀 Accelerate your success. Contact us now
📂 Explore our case studies. See examples of our work.
💡 Read our insights. Learn from our latest reports and analysis
🎬 Watch on YouTube. Subscribe and never miss a video.
🧰 See our full range of services. Discover how we can help you.
Discover the full Oncology archive on our research hub page.
FAQ
What did the FDA accept for Nuvalent’s zidesamtinib and when is the action date?
FDA accepted the NDA for ROS1-positive NSCLC after at least 1 prior ROS1 TKI, with a PDUFA target of 18 Sep 2026 [1]. Details beyond ARROS-1 are not specified.
How was HYRNUO (sevabertinib) approved and in which population?
Under accelerated approval for adult non-squamous NSCLC with activating HER2 TKD mutations after prior systemic therapy, based on ORR and DoR from SOHO-01 [2].
What is being submitted for zipalertinib?
A rolling NDA seeking accelerated approval in EGFR exon 20 insertion NSCLC post-platinum, supported by REZILIENT1 data; completion targeted 1Q 2026 per company statement [3].
What evidence supported IMDELLTRA’s full approval in ES-SCLC?
DeLLphi-304 showed a 40% reduction in risk of death vs chemotherapy and improved median OS, converting to full approval post-platinum [4].
What is distinctive about KEYTRUDA SC in Europe?
It is the first subcutaneous checkpoint inhibitor approved across all adult EU indications, with 1–2 minute administration and PK comparability to IV pembrolizumab in D77 [10].
What was approved for Braftovi in Japan’s CRC?
Supplemental approval for encorafenib + cetuximab + FOLFOX as first-line in unresectable, advanced or recurrent BRAFV600E-mutant CRC based on BREAKWATER [8].
Entities / Keywords
Nuvalent; zidesamtinib; ROS1 NSCLC; ARROS-1
Bayer; HYRNUO; sevabertinib; HER2 TKD mutation NSCLC; SOHO-01
Taiho Oncology; Cullinan Therapeutics; zipalertinib; CLN-081; TAS6417; EGFR exon 20 insertion; REZILIENT1
Amgen; IMDELLTRA; tarlatamab; DLL3; ES-SCLC; DeLLphi-304
Celcuity; gedatolisib; pan-PI3K/mTOR; VIKTORIA-1; HR+/HER2-; PIK3CA wild-type
Dewpoint Therapeutics; DPTX3186; condensate modulator; Wnt/β-catenin; gastric cancer; Fast Track
Oncolytics Biotech; pelareorep; mPDAC; pivotal Phase 3; checkpoint inhibitor
Ono Pharmaceutical; Braftovi; encorafenib; cetuximab; FOLFOX; BREAKWATER; BRAFV600E; Japan approval
Regeneron; Libtayo; cemiplimab; CSCC; adjuvant; C-POST; EU approval
Merck; KEYTRUDA SC; pembrolizumab; berahyaluronidase alfa; subcutaneous PD-1; EU approval
References
- https://investors.nuvalent.com/2025-11-19-Nuvalent-Announces-FDA-Acceptance-of-New-Drug-Application-for-Zidesamtinib-for-the-Treatment-of-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC
- https://www.bayer.com/en/us/news-stories/hyrnuo
- https://www.taihooncology.com/us/news/taiho-oncology-taiho-pharmaceutical-and-cullinan-therapeutics-initiate-rolling-submission-of-new-drug-application-to-us-food-and-drug-administration-for-zipalertinib-for-treatment-of-locally-advanced-or-metastatic-non-small-cell-lung-cancer-with-egfr-e/
- https://www.amgen.com/newsroom/press-releases/2025/11/fda-grants-full-approval-to-amgens-imdelltra-in-extensive-stage-small-cell-lung-cancer
- https://www.biospace.com/press-releases/celcuity-announces-completion-of-submission-of-its-new-drug-application-to-the-u-s-fda-for-gedatolisib-in-hr-her2-pik3ca-wild-type-advanced-breast-cancer
- https://dewpointx.com/fda-grants-fast-track-designation-to-dewpoint-therapeutics-dptx3186-for-the-treatment-of-gastric-cancer/
- https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-aligns-with-fda-on-pivotal-study-design-for-pelareorep-in-first-line-pancreatic-cancer/
- https://www.ono-pharma.com/en/news/20251120.html
- https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-approved-european-union-first-and-only
- https://www.businesswire.com/news/home/20251119081276/en/European-Commission-Approves-Subcutaneous-Administration-of-KEYTRUDA-pembrolizumab-for-All-Adult-Indications-Approved-in-the-European-Union