FDA Considers Expanding Keytruda Use for Advanced Melanoma
The FDA is considering expanding the use of Merck's pembrolizumab as a first-line treatment for advanced melanoma.
The FDA is considering expanding the use of Merck’s pembrolizumab (Keytruda) as a first-line treatment for advanced melanoma.
Keytruda has received Priority Review for this new indication from the FDA, which is now expected to make its approval decision on December 19, 2015.
The supplemental Biologics License Application (sBLA) for Keytruda as a first-line treatment for unresectable or metastatic melanoma patients was partially based on data from the phase 3 KEYNOTE-006 trial, which evaluated the drug in 834 patients.
Keytruda is currently approved at a dose of 2 mg/kg infused over 30 minutes every 3 weeks in patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, for those who are BRAF V600 mutation positive, a BRAF inhibitor.
The FDA has also extended its action date for a separate Keytruda sBLA for the treatment of patients with ipilimumab-refractory advanced melanoma to December 24, 2015.