Abbisko Therapeutics Announces That Its CSF-1R Inhibitor Pimicotinib (ABSK021) Has Been Granted Fast Track Designation by the U.S. FDA
Thursday, December 14, 2023
Abbisko Therapeutics Co., Ltd. has announced that the U.S. FDA has granted fast track designation (FTD) for its CSF-1R inhibitor pimicotinib (ABSK021) in the treatment of tenosynovial giant cell tumor (TGCT) patients who are not candidates for surgery. This designation follows the breakthrough therapy designation (BTD) given in January 2023. The FTD and BTD are expected to expedite the global development and commercialization of pimicotinib, allowing for accelerated approval and priority review by the U.S. FDA.
The Fast Track program is designed to hasten drug development for serious conditions, addressing unmet medical needs and facilitating early patient access. It also enables increased communication between companies and the FDA, and the drug becomes eligible for accelerated approval and priority review.
Abbisko recently secured an exclusive agreement with Merck KGaA, Darmstadt, Germany, granting it the exclusive license to commercialize pimicotinib in China mainland, Hong Kong, Macau, and Taiwan. Merck KGaA also holds an exclusive option for global commercial rights. Under the agreement, Abbisko will receive a one-time payment of US$ 70 million, with potential additional payments totaling US$ 605.5 million based on milestones and royalties.
Pimicotinib, an orally available CSF-1R inhibitor developed by Abbisko, has demonstrated promise in a Phase 1b trial with an overall response rate (ORR) of 87.5% in TGCT patients not amenable to surgery. The drug has received BTD and Priority Medicine (PRIME) designation from regulatory authorities in China, the U.S., and Europe. The Phase III clinical trial for TGCT is the first to be conducted globally in China, the U.S., Canada, and Europe.
In addition to TGCT, Abbisko is exploring pimicotinib's potential in treating various solid tumors, with approval from the China National Medical Products Administration (NMPA) for a Phase II clinical study in chronic graft-versus-host disease and advanced pancreatic cancer. Notably, no highly selective CSF-1R inhibitors have been approved in China to date.
Tenosynovial giant cell tumor (TGCT) is a locally aggressive neoplasm affecting synovial joints, mucous sacs, and tendon membranes, leading to swelling, pain, and reduced joint activity. Surgical resection is the standard treatment, but not all patients are suitable for surgery, and there is currently no approved drug in China for those not amenable to surgery.
Source: prnasia.com
