The FDA granted priority review to pembrolizumab for the first-line treatment of patients with unresectable or metastatic melanoma, according to a press release from the drug’s manufacturer.
Regulatory
Frontline Pembrolizumab Receives FDA Priority Review in Melanoma
The FDA has granted a priority review to pembrolizumab (Keytruda) as a frontline treatment for patients with advanced melanoma, according to Merck, the manufacturer of the anti–PD-1 therapy. A final decision is scheduled from the FDA by December 19, 2015.
FDA Delays Decision on Frontline Nivolumab in Melanoma
The FDA has extended the review period for frontline nivolumab (Opdivo) in patients with advanced melanoma by 3 months, to allow ample time to review additional data submitted by the PD-1 inhibitor’s developer Bristol-Myers Squibb (BMS). The updated action date for the new indication is November 27, 2015.
FDA grants priority review of Tafinlar/Mekinist for adults with BRAF V600mutation-positive melanoma
Novartis announced that the FDA has granted priority review of the combination of Tafinlar and Mekinist for adults with unresectable or metastatic melanoma with a BRAF V600 mutation.