The US Food and Drug Administration (FDA) has granted nivolumab (Opdivo), a PD-1 pathway inhibitor, accelerated approval for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other treatments. The drug has been granted breakthrough designation, priority review and orphan product designation.
Regulatory
FDA approves Opdivo for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.
Genentech Files NDA For Two-Pill Combo In Melanoma In U.S.
Roche Group member Genentech announced that it has filed the New Drug Application (NDA) for its two-pill combo therapy cobimetinib and Zelboraf (vemurafenib) with the U.S. Food and Drug Administration (FDA) as treatment for BRAF V600 mutation-positive advanced melanoma.
Genentech Submits NDA For Cobimetinib With Zelboraf To Treat Advanced Melanoma
Genentech, a part of Swiss pharmaceutical giant Roche Holding AG (RHHBY.PK, ROG.SW, RO.SW), Monday announced that it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for Investigational Cobimetinib used in combination with Zelboraf (vemurafenib).