The FDA issued final guidances on performance status, washout periods, and laboratory values aimed at expanding oncology trial participation.
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The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) reviewed data from the phase 1/2 IGNYTE trial (NCT03767348) evaluating vusolimogene oderparepvec (RP1) plus nivolumab (Opdivo) in advanced cutaneous melanoma that progressed on an anti–PD-1–based regimen. What was the outcome of the committee's vote?
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The FDA’s CTGTAC voted that the data from the IGNYTE trial are evaluable and clinically meaningful for RP1/nivolumab in advanced cutaneous melanoma.
The FDA has granted priority review to subcutaneous amivantamab and hyaluronidase-lpuj for adults with recurrent or metastatic head and neck cancer.
Leukocyte interleukin injection improved OS in patients with oral cancer expressing low tumor PD-L1 levels.
The Cellular, Tissue, and Gene Therapies Advisory Committee will review Replimune’s twice-rejected BLA for RP1 plus nivolumab in advanced melanoma.
Experts reveal their top picks for gastrointestinal oncology presentations from the 2026 ASCO Annual Meeting.
Laurence J. DiNardo, MD, FACS, discusses ctDNA testing in head and neck cancers, advancements in targeted therapies, and multidisciplinary collaboration.
Sonesitatug vedotin improved overall survival in pretreated CLDN18.2-positive advanced gastric/GEJ cancers in the phase 3 CLARITY-Gastric01 trial.
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