The FDA expanded the approval of nivolumab plus ipilimumab to include all patients with unresectable or metastatic melanoma, regardless of BRAF V600 mutational status.
Regulatory
FDA Expands Nivolumab’s Frontline Melanoma Approval to Include BRAF-Mutant Patients
The FDA has expanded the frontline melanoma indications for nivolumab (Opdivo) as a single agent and in combination with ipilimumab (Yervoy) to include patients with BRAF V600 mutations, based on data from the phase III CheckMate-067 trial.
FDA Expands Pembrolizumab Label for Melanoma
The US Food and Drug Administration (FDA) recently expanded its approval of pembrolizumab (Keytruda) to include the initial treatment of patients with unresectable or metastatic melanoma. In 2014, pembrolizumab was approved for patients with unresectable or metastatic melanoma who progressed after treatment with ipilimumab and, if BRAF V600–mutation positive, a BRAF inhibitor.
FDA approves expanded indication for Merck’s Keytruda
The US Food and Drug Administration has approved an expanded indication for Merck’s Keytruda (pembrolizumab)…