Onyx Pharmaceuticals, a licensee of Ligand Pharmaceuticals, has gained FDA approval for Kyprolis (carfilzomib) for injection.
Kyprolis is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
The approval was based on the results of the Phase 2b 003-A1 study, a single-arm trial that enrolled 266 patients with multiple myeloma, who had received a median of five prior anti-myeloma regimens.
The primary efficacy endpoint was overall response and determined by an Independent Review Committee using the International Myeloma Working Group criteria. ORR was 22.9% and median response duration was 7.8 months.
Ligand president and chief executive officer John Higgins said the Captisol license agreement with Onyx is a highly asset for Ligand, and the company looks forward to the near-term launch of the product.
"The approval of Kyprolis further demonstrates the clinical advantages and commercial potential of Captisol," Higgins added.
Kyprolis is formulated with Ligand's Captisol, which improves drug solubility and enables a reduced drug load.