Nivolumab sBLA Accepted for Patients With Completely Resected Stage IIB, IIC Melanoma
The sBLA is supported by data from the phase 3 CheckMate -76K trial which included 790 patients after complete resection of stage IIB or IIC melanoma.
Diagnosis & Disease Information
FDA: Cases of Breast Implant-Related SCC, Various Lymphomas Reported
Following an initial extensive review, the Agency identified less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant.
Opdualag Approved for Unresectable, Metastatic Melanoma
Opdualag is a fixed-dose combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody.
Keytruda Approved for Adjuvant Treatment IIB, IIC Melanoma Following Resection
Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.
Relatlimab-Nivolumab Fixed-Dose Combo Gets Priority Review for Melanoma
The application is supported by data from the phase 2/3 RELATIVITY-047 trial.
Nemvaleukin Alfa Fast Tracked for Mucosal Melanoma
Nemvaleukin alfa is an investigational, engineered fusion protein consisting of modified interleukin-2 (IL-2) and the high-affinity IL-2 alpha receptor chain.
Lymphoseek Approval Expanded to Pediatric Patients
The approval was based on data from a phase 2 trial that assessed Lymphoseek in pediatric patients with melanoma, RMS, or other solid tumors.
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