Abbisko Therapeutics has recently disclosed that its CSF-1R inhibitor, pimicotinib (ABSK021), has been granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of tenosynovial giant cell tumor (TGCT) patients who are not candidates for surgery. This follows the earlier breakthrough therapy designation (BTD) granted by the U.S. FDA for TGCT in January 2023. The FTD and BTD designations are expected to expedite the global development and commercialization of pimicotinib.
Fast Track is a regulatory policy aimed at facilitating the development and expediting the review of drugs intended to address serious conditions and unmet medical needs. It seeks to bring vital new drugs to patients more swiftly, allowing for accelerated approval and priority review by the U.S. FDA. The FTD also enables increased communication and meetings between the drug developer and the FDA.
Pimicotinib, an orally available CSF-1R inhibitor, has been independently developed by Abbisko Therapeutics and has received BTD and Priority Medicine (PRIME) designation from the China National Medical Products Administration (NMPA), U.S. FDA, and the European Medicines Agency (EMA) for treating TGCT patients ineligible for surgery. This marks the initiation of the first global Phase III clinical trial of TGCT, simultaneously conducted in China, the U.S., Canada, and Europe.
TGCT is a locally aggressive neoplasm affecting synovial joints, mucous sacs, and tendon membranes, causing swelling, pain, stiffness, and reduced joint activity. Overexpression of CSF-1 is observed in most TGCTs. While surgical resection is the standard treatment, not all patients are suitable for surgery. Diffuse TGCT, in particular, presents challenges for surgical removal, with a high risk of recurrence after surgery.
The FTD for pimicotinib underscores its potential in addressing an unmet medical need, particularly for TGCT patients who are not candidates for surgery, and represents a significant step forward in advancing the development and regulatory processes for this promising treatment option.
