Abbisko Therapeutics’ Pimicotinib (ABSK021) Receives US FDA’s Fast Track Designation for Treating Tenosynovial Giant Cell Tumor
Shots:
- The US FDA has granted FTD to the company’s pimicotinib (CSF-1R inhibitor) based on the 1yr. follow-up data from the P-Ib study of pimicotinib for patients with TGCT revealing 87.5% ORR (28/32, incl. 3 CR) in the 50 mg QD arm
- The drug has previously received BTD from the US FDA and PRIME designation for the EMA for TGCT
- As per Merck KGaA & Abbisko's agreement signed in early Dec 2023, Merck KGaA received the exclusive development rights for pimicotinib in Greater China with an option for global commercialization while Abbisko received $70M down payment, $605.5M up front, option exercise, and milestone payments, plus double-digit royalties (in %)
Ref: Abbisko Therapeutics| Image: Abbisko Therapeutics
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
