IvelinRadkov
The FDA has granted expanded approval for Merck’s (NYSE:MRK) oncology drug Keytruda in the treatment of non-small cell lung cancer, or NSCLC.
Keytruda, also known as pembrolizumab, was approved as a neoadjuvant and post-surgical adjuvant for patients with resectable NSCLC, according to Bloomberg.
Merck had applied to have Keytruda approved for use in combination with platinum containing chemotherapy as a neoadjuvant treatment and then continued as a single agent adjuvant treatment in patients with resectable stage II, IIIA or IIIB NSCLC. The FDA was expected to make a decision on the approval by Oct. 16, according to the company.
Earlier Monday, the EU regulators approved Keytruda as a monotherapy for the adjuvant treatment of patients with NSCLC who are at high risk for recurrence following platinum-based chemotherapy and complete resection.
Keytruda is already approved to treat 16 types of cancer, including triple-negative breast cancer, kidney cancer, NSCLC, cervical cancer and melanoma.