This week’s Oncology update covers a mix of regulatory actions, filing milestones, clinical-trial progress, and new data disclosures across solid tumors and hematology-adjacent immuno-oncology approaches.
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🧬 Calidi shares RedTail viral BiTE approach in solid tumors [1] [US • 20 Feb 2026]
Context: RedTail is a systemically delivered oncolytic virus platform, CLD-401 is engineered to express an IL-15 superagonist in the tumor microenvironment.
Key point: Calidi presented conference data indicating RedTail viruses can co-express a functional solid-tumor targeting BiTE and IL-15 at high concentrations (pre-clinical).
Implication: Signals pipeline investment and modality expansion.
🧪 AVEO selects ficlatuzumab dose for Phase 3 FIERCE-HN combo arm [2] [US • 18 Feb 2026]
Context: FIERCE-HN is a global, randomized, double-blind Phase 3 trial in HPV-negative R/M HNSCC evaluating ficlatuzumab plus cetuximab vs placebo plus cetuximab.
Key point: AVEO said 20 mg/kg ficlatuzumab was selected for the combination arm after the planned first interim analysis (per IDMC recommendation and FDA alignment).
Implication: Signals pipeline investment and modality expansion.
🫁 Lilly reports Phase 3 LIBRETTO-432 adjuvant topline for Retevmo [3] [US • 16 Feb 2026]
Context: LIBRETTO-432 is a Phase 3, randomized, double-blind trial of selpercatinib vs placebo after definitive radiotherapy or surgery with curative intent in RET fusion+ NSCLC.
Key point: Lilly said the study met its primary endpoint with a highly statistically significant improvement in investigator-assessed event-free survival in the stage II–IIIA population.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 FDA approves monthly dosing for RYBREVANT FASPRO in EGFR-mutated NSCLC [4] [US • 17 Feb 2026]
Context: RYBREVANT FASPRO is subcutaneous amivantamab co-formulated with hyaluronidase, used with LAZCLUZE in 1L EGFR-mutated advanced NSCLC, with monthly dosing beginning as early as week 5 (per source).
Key point: J&J said FDA approved a once-monthly dosing schedule, citing consistent outcomes versus the previously approved bi-weekly SC schedule.
Implication: May influence prescriber choice and payer reviews pending full data.
📝 Roche NDA accepted for giredestrant plus everolimus in ESR1-mutated ER+ MBC [5] [US • 20 Feb 2026]
https://www.roche.com/media/releases/med-cor-2026-02-20
Context: Filing seeks giredestrant plus everolimus in adult patients with ER+, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer after prior endocrine-based therapy.
Key point: Roche said FDA accepted the NDA and set a PDUFA date of 18 Dec 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🎗️ ENHERTU EU Type II variation validated for post-neoadjuvant HER2+ EBC [6] [EU • 19 Feb 2026]
https://www.daiichisankyo.com/files/news/pressrelease/pdf/202602/20260219_E.pdf
Context: Application covers ENHERTU monotherapy for HER2+ early breast cancer with residual invasive disease after neoadjuvant HER2-targeted treatment.
Key point: Daiichi Sankyo and AstraZeneca said EMA validated the Type II variation application, starting CHMP scientific review (supported by DESTINY-Breast05).
Implication: May influence prescriber choice and payer reviews pending full data.
🏷️ Pilatus wins FDA Fast Track for PLT012 (anti-CD36) in HCC [7] [US • 19 Feb 2026]
Context: PLT012 is a first-in-class anti-CD36 monoclonal antibody, Phase 1 study is open for enrollment (sites stated in source).
Key point: Pilatus said FDA granted Fast Track designation for PLT012 for hepatocellular carcinoma.
Implication: Signals pipeline investment and modality expansion.
🌍 European Commission authorizes ANKTIVA plus BCG for BCG-unresponsive NMIBC CIS [8] [EU • 18 Feb 2026]
Context: Conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept) plus BCG in NMIBC CIS (with or without papillary tumors), with ongoing follow-up commitments (per source).
Key point: ImmunityBio said the European Commission granted conditional marketing authorization across EU member states plus Iceland, Norway, and Liechtenstein.
Implication: May influence prescriber choice and payer reviews pending full data.
💰 Candel signs $100M royalty funding agreement with RTW for CAN-2409 launch support [9] [US • 19 Feb 2026]
Context: Funding becomes available upon FDA approval of aglatimagene besadenovec (CAN-2409) for intermediate- to high-risk localized prostate cancer (per source).
Key point: Candel said RTW committed $100M in U.S. launch funding (subject to FDA approval) and Candel expects to submit a BLA in Q4 2026.
Implication: Signals pipeline investment and modality expansion.
🏥 MHRA approves zanidatamab (Ziihera) for HER2-high biliary tract cancer [10] [UK • 19 Feb 2026]
Context: Adults with unresectable, locally advanced or metastatic biliary tract cancer with high HER2 whose disease progressed after prior treatment, zanidatamab is given every two weeks (per MHRA).
Key point: MHRA approved zanidatamab (Ziihera), citing a single-arm study (no comparator).
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- Regulatory milestones cluster across oncology, including an FDA NDA acceptance with a stated PDUFA date, an FDA dosing label change, and EU and UK authorization decisions. [4], [5], [8], [10]
- Adjuvant targeted therapy data in RET fusion+ NSCLC adds pressure to expand biomarker testing and earlier-line targeted use, pending full dataset release. [3]
- Fast Track and platform updates reinforce continued investment in differentiated immuno-oncology mechanisms. [1], [7]
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FAQ
What did Roche file, and when is the decision expected?
Roche said FDA accepted an NDA for giredestrant plus everolimus in ESR1-mutated, ER+ advanced breast cancer, and set a PDUFA date of 18 Dec 2026. [5]
What changed for RYBREVANT FASPRO in the US?
J&J said FDA approved a once-monthly dosing schedule for RYBREVANT FASPRO when used with LAZCLUZE in 1L EGFR-mutated advanced NSCLC. [4]
What is the key topline claim for LIBRETTO-432 (Retevmo)?
Lilly said the Phase 3 trial met its primary endpoint with a highly statistically significant improvement in investigator-assessed EFS in the stage II–IIIA population. [3]
What did the European Commission authorize for ANKTIVA?
ImmunityBio said the European Commission granted conditional marketing authorization for ANKTIVA plus BCG in BCG-unresponsive NMIBC CIS (with or without papillary tumors). [8]
What did the MHRA approve zanidatamab for?
MHRA approved zanidatamab (Ziihera) for adults with HER2-high biliary tract cancer after prior treatment, noting evidence from a single-arm study. [10]
Entities / Keywords
Calidi Biotherapeutics (CLDI), RedTail, CLD-401, BiTE, IL-15 superagonist, tumor microenvironment
AVEO Oncology (LG Chem), ficlatuzumab, cetuximab (Erbitux), FIERCE-HN, HPV-negative R/M HNSCC
Eli Lilly, Retevmo (selpercatinib), LIBRETTO-432, RET fusion-positive NSCLC, adjuvant, event-free survival
Johnson & Johnson, RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), LAZCLUZE (lazertinib), EGFR-mutated NSCLC
Roche, giredestrant, everolimus, evERA, ESR1-mutated, ER-positive breast cancer, NDA, PDUFA
Daiichi Sankyo, AstraZeneca, ENHERTU (trastuzumab deruxtecan), DESTINY-Breast05, EMA Type II variation, HER2+ early breast cancer
Pilatus Biosciences, PLT012, anti-CD36, metabolic checkpoint, Fast Track, hepatocellular carcinoma
ImmunityBio, ANKTIVA (nogapendekin alfa inbakicept), BCG, NMIBC CIS, EC conditional marketing authorization
Candel Therapeutics, aglatimagene besadenovec (CAN-2409), RTW, royalty funding, BLA
MHRA, zanidatamab (Ziihera), HER2-high biliary tract cancer
References
[5] https://www.roche.com/media/releases/med-cor-2026-02-20
[6] https://www.daiichisankyo.com/files/news/pressrelease/pdf/202602/20260219_E.pdf