This week’s Oncology update highlights regulatory approvals, NDA submissions and acceptances, clinical progress, guideline shifts, and commercialization activity across multiple biomarker-driven cancers.
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🫁 Ivonescimab CSCO NSCLC guideline upgrades [1] [China • 28 Apr 2026]
https://www.akesobio.com/en/media/akeso-news/260428/
Context: Ivonescimab (Akeso; PD-1/VEGF bispecific antibody) was reviewed in 2026 CSCO NSCLC guideline updates.
Key point: CSCO upgraded ivonescimab monotherapy to Class I in first-line PD-L1 TPS ≥1% squamous and non-squamous NSCLC.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Zipalertinib FDA NDA acceptance in EGFR ex20ins NSCLC [2] [US • 28 Apr 2026]
https://www.taiho.co.jp/en/release/2026/20260428_1.html
Context: Zipalertinib (Taiho, Cullinan; oral EGFR TKI) was evaluated in REZILIENT1 for previously treated EGFR ex20ins NSCLC.
Key point: FDA accepted the NDA, with a PDUFA target action date of 27 Feb 2027.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 VEPPANU FDA approval in ESR1m ER+/HER2- breast cancer [3] [US • 01 May 2026]
https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-fda-approval-veppanu-vepdegestrant-treatment
Context: VEPPANU (vepdegestrant; Arvinas, Pfizer) is an oral PROTAC estrogen receptor degrader.
Key point: FDA approved VEPPANU for ESR1-mutated ER+/HER2- advanced or metastatic breast cancer after endocrine therapy.
Implication: May influence prescriber choice and payer reviews pending full data.
🍽️ Ziihera Priority Review in first-line HER2+ GEA [4] [US • 27 Apr 2026]
https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0
Context: Ziihera (zanidatamab-hrii; Jazz, BeOne) was studied in HERIZON-GEA-01 with chemotherapy, with or without tislelizumab.
Key point: FDA accepted the sBLA with Priority Review for first-line HER2+ unresectable locally advanced or metastatic GEA.
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 Varegacestat NDA submission in desmoid tumors [5] [US • 29 Apr 2026]
https://investors.immunome.com/immunome-announces-submission-of-new-drug-application-to-u-s-fda-for-varegacestat-for-the-treatment-of-adults-with-desmoid-tumors/
Context: Varegacestat (Immunome; oral gamma secretase inhibitor) was studied in Phase 3 RINGSIDE.
Key point: Immunome submitted an NDA for adults with desmoid tumors, supported by positive Phase 3 data.
Implication: May influence prescriber choice and payer reviews pending full data.
👁️ Darovasertib RTOR path in metastatic uveal melanoma [6] [US • 30 Apr 2026]
https://media.ideayabio.com/2026-04-30-IDEAYA-Biosciences-to-Initiate-New-Drug-Application-Submission-from-the-Darovasertib-OptimUM-02-Trial-under-the-Oncology-Center-of-Excellence-Real-time-Oncology-Review-RTOR-Program
Context: Darovasertib plus crizotinib (IDEAYA) was tested in OptimUM-02 for first-line HLA*A2-negative metastatic uveal melanoma.
Key point: FDA agreed to review the NDA under RTOR, with IDEAYA planning first pre-submission in May 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🛡️ iSCIB1+ FDA Fast Track in advanced melanoma [7] [US • 28 Apr 2026]
https://scancell.co.uk/wp-content/uploads/2026/04/Scancell-Receives-FDA-Fast-Track-Designation-Press-Release.pdf
Context: iSCIB1+ (Scancell; ImmunoBody active immunotherapy) is being studied with ipilimumab and nivolumab in SCOPE Phase 2.
Key point: FDA granted Fast Track designation for iSCIB1+ in advanced melanoma.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Pelareorep pivotal anal cancer study alignment [8] [US • 27 Apr 2026]
https://ir.oncolyticsbiotech.com/press_releases/oncolytics-aligns-with-fda-on-planned-pivotal-anal-cancer-study/
Context: Pelareorep (Oncolytics; intravenously delivered immunotherapy) is being developed for metastatic squamous cell anal carcinoma.
Key point: Oncolytics aligned with FDA on a randomized pivotal study design in a post-standard-of-care population.
Implication: May influence prescriber choice and payer reviews pending full data.
🎯 Truqap ODAC vote in PTEN-deficient mHSPC [9] [US • 30 Apr 2026]
https://www.astrazeneca.com/media-centre/press-releases/2026/fda-odac-recommends-truqap-prostate-cancer.html
Context: Truqap (capivasertib; AstraZeneca) plus abiraterone and ADT was evaluated in CAPItello-281.
Key point: FDA ODAC voted 7 to 1, with 1 abstention, that the combination has a favorable benefit-risk profile in PTEN-deficient mHSPC.
Implication: May influence prescriber choice and payer reviews pending full data.
🤝 Candel, EVERSANA commercialization pact [10] [US • 29 Apr 2026]
https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-announces-commercialization-agreement
Context: Aglatimagene besadenovec (Candel; CAN-2409) is an investigational adenoviral immunotherapy for localized prostate cancer.
Key point: Candel entered a commercialization agreement with EVERSANA to support a potential US launch, subject to approval.
Implication: Signals pipeline investment and modality expansion.
Why it matters
- FDA oncology activity was broad, spanning approval, NDA acceptance, sBLA acceptance, RTOR, Fast Track, ODAC review, and pivotal-study alignment.
- Biomarker-defined cancers remained central, including ESR1m breast cancer, EGFR ex20ins NSCLC, HER2+ GEA, PTEN-deficient mHSPC, and HLA*A2-negative mUM.
- China guideline movement for ivonescimab shows non-US clinical adoption signals can shape global oncology narratives.
- Several companies are pairing regulatory progress with launch or commercialization planning before final approval decisions.
- Multiple oncology modalities advanced, including bispecific antibodies, targeted protein degradation, TKIs, immunotherapies, and gene-mediated immunotherapy.
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FAQ
What changed for ivonescimab in NSCLC?
Akeso said ivonescimab received upgraded and new CSCO NSCLC guideline recommendations. These include Class I first-line recommendations in PD-L1 TPS ≥1% squamous and non-squamous NSCLC. [1]
What is the FDA status of zipalertinib?
FDA accepted Taiho and Cullinan’s zipalertinib NDA for previously treated locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The PDUFA target action date is 27 Feb 2027. [2]
Why is VEPPANU notable?
VEPPANU (vepdegestrant) is described by Arvinas and Pfizer as the first FDA-approved PROTAC therapy. It is approved for ESR1-mutated ER+/HER2- advanced or metastatic breast cancer after endocrine therapy. [3]
What is Jazz seeking for Ziihera?
Jazz is seeking FDA approval for Ziihera combinations in first-line HER2+ unresectable locally advanced or metastatic GEA. The sBLA received Priority Review, with a PDUFA date of 25 Aug 2026. [4]
What did ODAC say about Truqap in prostate cancer?
ODAC voted 7 to 1, with 1 abstention, that Truqap plus abiraterone and ADT showed a favorable benefit-risk profile in PTEN-deficient metastatic hormone-sensitive prostate cancer. FDA is not bound by ODAC votes. [9]
What is Candel’s EVERSANA agreement for?
Candel said EVERSANA will support potential US commercialization of aglatimagene besadenovec in localized prostate cancer, subject to regulatory approval. [10]
Entities / Keywords
Akeso, ivonescimab, PD-1/VEGF bispecific antibody, CSCO, NSCLC, HARMONi-2, HARMONi-6
Taiho Oncology, Taiho Pharmaceutical, Cullinan Therapeutics, zipalertinib, CLN-081, TAS6417, EGFR exon 20 insertion, REZILIENT1
Arvinas, Pfizer, VEPPANU, vepdegestrant, PROTAC, ESR1m, ER+/HER2- breast cancer, VERITAC-2
Jazz Pharmaceuticals, BeOne Medicines, Ziihera, zanidatamab-hrii, Tevimbra, tislelizumab, HER2+ GEA, HERIZON-GEA-01
Immunome, varegacestat, AL102, gamma secretase inhibitor, desmoid tumors, RINGSIDE
IDEAYA Biosciences, darovasertib, crizotinib, OptimUM-02, metastatic uveal melanoma, HLA*A2-negative, RTOR
Scancell, iSCIB1+, ImmunoBody, SCOPE, advanced melanoma, FDA Fast Track
Oncolytics Biotech, pelareorep, squamous cell anal carcinoma, SCAC, pivotal study
AstraZeneca, Truqap, capivasertib, abiraterone, ADT, PTEN-deficient mHSPC, CAPItello-281, ODAC
Candel Therapeutics, EVERSANA, aglatimagene besadenovec, CAN-2409, localized prostate cancer
References
- https://www.akesobio.com/en/media/akeso-news/260428/
- https://www.taiho.co.jp/en/release/2026/20260428_1.html
- https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-fda-approval-veppanu-vepdegestrant-treatment
- https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0
- https://investors.immunome.com/immunome-announces-submission-of-new-drug-application-to-u-s-fda-for-varegacestat-for-the-treatment-of-adults-with-desmoid-tumors/
- https://media.ideayabio.com/2026-04-30-IDEAYA-Biosciences-to-Initiate-New-Drug-Application-Submission-from-the-Darovasertib-OptimUM-02-Trial-under-the-Oncology-Center-of-Excellence-Real-time-Oncology-Review-RTOR-Program
- https://scancell.co.uk/wp-content/uploads/2026/04/Scancell-Receives-FDA-Fast-Track-Designation-Press-Release.pdf
- https://ir.oncolyticsbiotech.com/press_releases/oncolytics-aligns-with-fda-on-planned-pivotal-anal-cancer-study/
- https://www.astrazeneca.com/media-centre/press-releases/2026/fda-odac-recommends-truqap-prostate-cancer.html
- https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-announces-commercialization-agreement