Abbisko Therapeutics Co., Ltd. (Abbisko Cayman Ltd.) announced that the U.S. Food and Drug Administration (FDA) has formally accepted the New Drug Application (NDA) for pimicotinib (ABSK021) for the systemic treatment of patients with tenosynovial giant cell tumor (TGCT). Pimicotinib, an orally administered, highly selective colony-stimulating factor 1 receptor (CSF-1R) inhibitor, was developed by Abbisko Therapeutics and is licensed to Merck KGaA, Darmstadt, Germany, for worldwide commercialization. The NDA acceptance is supported by data from the Phase III MANEUVER trial, which demonstrated statistically significant improvements in objective response rate and patient-reported outcomes. Pimicotinib was previously approved in China by the National Medical Products Administration (NMPA) for adult patients with symptomatic TGCT. Regulatory submissions for pimicotinib are also under review in other markets.

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