Oncology Today—March 2, 2026

This week’s Oncology update highlights major regulatory approvals, survival-driven Phase 3 data, global label expansions, and continued Fast Track momentum across targeted, radiopharmaceutical, and gene therapy platforms.

In Today’s Newsletter

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💉 J&J: SC RYBREVANT dosing expansion in EU NSCLC [1] [EU • 23 Feb 2026]

https://www.jnj.com/media-center/press-releases/subcutaneous-rybrevant-amivantamab-approved-by-european-commission-for-every-three-week-and-every-four-week-dosing-for-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer
Context: Phase 2 PALOMA-2 and Phase 1b PALOMA supported feasibility, PK, efficacy, safety (trial IDs cited in source).
Key point: European Commission approved Q3W and Q4W subcutaneous amivantamab regimens across previously approved IV indications in EGFR-mutated advanced NSCLC.
Implication: Regulatory/generics, Introduces competition that may affect pricing and formulary access.

🧬 ImmunityBio: ANKTIVA commercial and authorization updates [2] [US • 23 Feb 2026]

https://immunitybio.com/immunitybio-reports-700-year-over-year-revenue-growth-expanded-anktiva-approvals-in-lung-cancer-and-global-commercial-partnerships-in-33-countries-with-label-expansion-plans-globally/
Context: Company reported full-year 2025 net product revenue and described jurisdiction-level authorizations, partnerships, and trial programs (design details vary by program).
Key point: ImmunityBio reported ~700% year-over-year revenue growth for ANKTIVA and highlighted authorizations across 33 countries, including a Saudi conditional accelerated approval for ANKTIVA + checkpoint inhibitors in metastatic NSCLC.
Implication: Partnerships/BD, Signals pipeline investment and modality expansion.

🧪 MAIA: ateganosine positioning in 3L NSCLC [3] [US • 24 Feb 2026]

https://ir.maiabiotech.com/news-events/press-releases/detail/167/maia-biotechnologys-phase-3-momentumdemonstrates
Context: Company communication centered on a 2026 shareholder letter and ongoing Phase 3 program (endpoint details not specified in the excerpt).
Key point: MAIA emphasized ateganosine (telomere-targeting agent) development strategy in third-line NSCLC and referenced FDA Fast Track as part of its regulatory path narrative.
Implication: Clinical topline/efficacy, May influence prescriber choice and payer reviews pending full data.

🧠 Siren: FDA Fast Track for SRN-101 in recurrent high-grade glioma [4] [US • 24 Feb 2026]

https://sirenbiotechnology.com/siren-biotechnology-receives-fda-fast-track-designation-for-srn-101-for-the-treatment-of-recurrent-high-grade-glioma/
Context: Company states FDA cleared its first IND for SRN-101 enabling first-in-human evaluation (trial specifics not stated).
Key point: FDA granted Fast Track designation to SRN-101 (AAV-based immuno-gene therapy) for recurrent high-grade glioma.
Implication: Clinical topline/efficacy, May influence prescriber choice and payer reviews pending full data.

🇯🇵 Alpha Tau: Japan marketing approval for Alpha DaRT [5] [Japan • 24 Feb 2026]

https://www.alphatau.com/single-post/alpha-tau-medical-receives-japanese-marketing-approval-for-alpha-dart-in-unresectable-locally-advan
Context: Approval requires a post-market surveillance study (66 patients, five centers) per company statement.
Key point: Japan MHLW granted Shonin marketing approval for Alpha DaRT in unresectable locally advanced or locally recurrent head and neck cancer.
Implication: Regulatory/generics, Introduces competition that may affect pricing and formulary access.

🧫 Oncolytics: pelareorep focus shifts to registrational SCAC and CRC [6] [24 Feb 2026]

https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-to-prioritize-registration-focused-programs-in-anal-and-colorectal-cancer/
Context: Company said it concluded enrollment in the GOBLET Phase 1/2 GI study and plans a US-based SCAC registrational approach (design under discussion).
Key point: Oncolytics will wind down parts of GOBLET to prioritize registration-focused programs for pelareorep in squamous cell anal cancer and metastatic colorectal cancer.
Implication: Partnerships/BD, Signals pipeline investment and modality expansion.

✅ Pfizer: full FDA approval for BRAFTOVI combo in 1L BRAF V600E mCRC [7] [US • 24 Feb 2026]

https://www.pfizer.com/news/press-release/press-release-detail/us-fda-grants-full-approval-pfizers-braftovi-combination
Context: BREAKWATER Phase 3 evaluated encorafenib + cetuximab with fluorouracil-based chemotherapy (mFOLFOX6 and FOLFIRI cohorts described in source).
Key point: FDA granted full approval for BRAFTOVI (encorafenib) + cetuximab + fluorouracil-based chemotherapy in 1L BRAF V600E–mutant mCRC, converting a prior accelerated approval.
Implication: Clinical topline/efficacy, May influence prescriber choice and payer reviews pending full data.

☢️ Aktis: FDA Fast Track for AKY-1189 in metastatic urothelial cancer [8] [US • 24 Feb 2026]

https://investors.aktisoncology.com/news-releases/news-release-details/aktis-oncology-receives-us-fda-fast-track-designation-aky-1189
Context: Ongoing Phase 1b study (NCT07020117) enrolling mUC and other Nectin-4 expressing tumors, per company.
Key point: FDA granted Fast Track designation to AKY-1189 (Nectin-4 miniprotein radioconjugate delivering actinium-225) for adults with locally advanced or metastatic urothelial cancer after prior systemic therapy.
Implication: Clinical topline/efficacy, May influence prescriber choice and payer reviews pending full data.

🦴 Bayer: PEACE-3 final OS benefit for enzalutamide + radium-223 [9] [Germany–US • 26 Feb 2026]

https://www.bayer.com/media/en-us/bayers-radium-223-dichloride-plus-enzalutamide-demonstrates-significant-overall-survival-benefit-in-the-peace-3-trial-in-patients-with-metastatic-castration-resistant-prostate-cancer-with-bone-metastases/
Context: PEACE-3 randomized Phase 3 in first-line mCRPC with bone metastases, 1:1 enzalutamide vs enzalutamide + radium-223 (details in source).
Key point: Bayer reported final OS results showing reduced risk of death with enzalutamide + radium-223 vs enzalutamide alone in bone-metastatic mCRPC.
Implication: Clinical topline/efficacy, May influence prescriber choice and payer reviews pending full data.

👧 Ipsen: positive CHMP opinion for Ojemda in BRAF-altered pLGG [10] [EU • 27 Feb 2026]

https://www.ipsen.com/press-release/ipsen-receives-positive-chmp-opinion-for-ojemda-for-the-treatment-as-monotherapy-of-children-with-relapsed-or-refractory-braf-altered-pediatric-low-grade-glioma-3246394/
Context: Opinion based on Phase II FIREFLY-1 in children and young adults with relapsed or refractory BRAF-altered pLGG (response criteria and safety described in source).
Key point: EMA CHMP recommended conditional marketing authorization for Ojemda (tovorafenib) monotherapy in patients aged 6 months+ with relapsed or refractory BRAF-altered pLGG after prior systemic therapy.
Implication: Regulatory/generics, Introduces competition that may affect pricing and formulary access.

Why it matters

• Multiple regulators moved on convenience and access levers, including SC administration and dosing flexibility (amivantamab) and pediatric targeted therapy review (tovorafenib). [1], [10]
• US oncology standards tightened in a biomarker-defined CRC segment via a full approval backed by Phase 3 outcomes (BRAFTOVI regimen). [7]
• Radiopharmaceutical and radiotherapy-adjacent programs advanced across modalities, from alpha-emitting platforms to targeted radioconjugates and combination OS evidence. [5], [8], [9]
• Several companies signaled sharper capital allocation toward registrational paths and specific indications. [6]