EMD Serono received FDA approval for its NDA, curing Tenosynovial Giant Cell Tumor

Introduction

EMD Serono, a strong business of Merck KGaA, is a polished tech and global science company known for the creative and unique treatment for complicated diseases such as cancer, infertility and multiple sclerosis. The company has reached a specific milestone due to its noteworthy research, marketing procedures and clinical insights in Massachusetts. EMD Serono’s mission is to discover, enhance and extend the life span for the severe patient group.

Announcement

FDA approved EMD Serono’s new drug application (NDA) for pimicotinib to introduce the systemic treatment for tenosynovial giant cell tumor (TGCT) patients. This application is related to the first results and long-standing revision of the global Phase 3 MANEUVER study. This study illustrates the timeframe and intensity of the significant improvements and responses in clinical results with pimicotinib. This approval will bring clinical development (study) to fruition with the proven results and confirmation.

Application

Under this application, the trial based on the existing results and follow-up for the same MANEUVER study will be capturing once-daily pimicotinib illustrations. This illustration encompasses the measurable improvement in the initial endpoint of objective response rate (ORR). The ORR is evaluated by a trusted, blinded independent review committee (BIRC) by RECIST v1.1. This study also noted clinically proven improvements in other endpoints based on major results in TGCT. These remarkable findings were screened at the ASCO Annual Meeting 2025.

About TGCT

TGCT is an extreme, violent tumor that leads to stiffness, shrinked mobility and swelling as well. These symptoms affect the day-to-day activities and a healthy life. This condition may cause damage to the joint and the tissues at the edges. For this threatening condition, the need for tolerable and effective treatments is essential, which is beyond surgical healing, relieving the pain and recovering the functionality, and reduce tumor volume.

Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck KGaA, Darmstadt, Germany, David Weinreich, said, “With this NDA for pimicotinib, we have reserved an opportunity to modernise the care sector for individuals living with TGCT. TGCT is a debilitating, stressful disease that doesn’t have many tolerable and effective treatment alternatives apart from surgery.”

“Regarding the clinical trial results, the mitigation of tumor stress and the capability of reducing symptoms of stiffness and pain were detected in the global Phase 3 MANEUVER study, and so we’re confident about pimicotinib.”