FDA OKs Keytruda Pleural Mesothelioma Indication

FDA has approved a new indication for Merck’s Keytruda (pembrolizumab) with pemetrexed (Lilly’s Alimta) and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). An agency statement says efficacy was investigated in the KEYNOTE-483 trial with the primary outcome measure of overall survival. Additional efficacy outcome measures were progression-free survival, objective response rate, and duration of response.

The statement says the review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among international partners. In this instance, FDA collaborated with the Australian Therapeutic Goods Administration and Health Canada. The review used the Assessment Aid voluntary submission and was granted priority review.