FDA accepts Merck KGaA’s pimicotinib NDA for tenosynovial giant cell tumor

Germany’s Merck KGaA (MRK: DE) has announced that the US Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) for pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumor (TGCT). 

The application is based on the primary results and longer-term follow-up of the global Phase III MANEUVER study, which demonstrated deep and durable tumor responses and meaningful improvements in clinical outcomes with pimicotinib.

David Weinreich, global head of R&D and chief medical officer for the healthcare business of Merck, said: “With pimicotinib, we have an opportunity to significantly advance care for people living with TGCT, a painful and debilitating disease that has few effective and well-tolerated treatment options beyond surgery.