Merck sBLA for Keytruda/Chemo in Mesothelioma

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with chemotherapy for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. The agency has set a 9/25 user fee review action target date.

The submission is based on data from the pivotal Phase 2/3 IND.227/KEYNOTE-483 trial that showed the combination demonstrated a statistically significant improvement in overall survival, reducing the risk of death by 21%, according to Merck. It also demonstrated a “significant improvement in progression-free survival” compared to chemotherapy alone, it says.

Malignant pleural mesothelioma is often diagnosed in advanced stages when curative surgery is not an option, and progresses rapidly, according to the company. It starts in the linings of certain parts of the body, including the chest, abdomen, heart and testicles.