Merck: FDA Approves KEYTRUDA With Carboplatin, Paclitaxel/Nab-Paclitaxel

(RTTNews) - Merck (MRK) announced the U.S. FDA has approved KEYTRUDA, the company's anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer. The approval is based on the results of Phase 3 KEYNOTE-407 trial, which demonstrated superior overall survival with KEYTRUDA in combination with Chemotherapy compared to chemotherapy alone.

"Today's approval expands our current lung cancer indications to include combination treatment in patients with squamous cell carcinoma, a type of lung cancer that is particularly difficult to treat," said Dr. Roger Perlmutter, president, Merck Research Laboratories.

The company noted that the approval marks the first time an anti-PD-1 regimen has been approved for the first-line treatment of squamous NSCLC regardless of tumor PD-L1 expression status.