Conditional approval expires for canine cancer drug

Five-year conditional approval for Kinavet-CA1 (masitinib mesylate) has ended, according to the U.S. Food and Drug Administration (FDA), and that means AB Science SA must cease marketing the drug in the United States. AB Science reports that testing of the drug will continue until full approval is reached.

The drug was given conditional approval to treat non-resectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids. AB Science says in a release that the company hopes to to complete the application for full approval by 2016.

Currently, AB Science says it is executing a prospective, multicenter, randomized, placebo-controlled phase 3 study to compare efficacy and safety of masitinib to placebo in the treatment of aggressive mast cell tumors in dogs not previously treated by chemotherapy or radiotherapy. An interim analysis based on the data of 74 dogs showed “statistically significant superiority on Time to Progression (Log-rank, p < 0.001).”

Masitinib is an orally administered tyrosine kinase inhibitor that targets mast cells and macrophages.

Kinavet-CA1 is fully approved in Europe by the European Medicine Agency (EMA) under the brand name Masivet.