Kinavet-CA1, a daily drug indicated for the treatment of mast cell tumors in dogs, is off the market in the United States at least temporarily because its five-year conditional approval expired.
The U.S. Food and Drug Administration reported today that sale of the oral tablets, produced by AB Science of Chatham, N.J., must cease immediately.
The company’s president of U.S. operations, Albert Ahn, DVM, expressed hope that Kinavet (mastinib mesylate) will return in the near future.
“The short answer is that we are working to make it the shortest timeline possible,” Dr. Ahn said. “We are working closely with the FDA. We are in regular contact with them.”
AB Science submitted documentation in a timely manner, he said.
“We have been, over the past five years, generating the data that are needed for earning full approval,” Ahn said. “The FDA has reviewed that information and apparently they feel that there may be some information that may not be complete.”
He called Kinavet an effective cancer drug.
“We are very, very proud of Kinavet,” he said. “It has helped thousands of dogs that have suffered from mast cell tumors, which is one of the most common canine cancers and unfortunately is too often deadly.
“We are 100 percent committed to bring Kinavet back to the market as a fully approved treatment for our canine companions.”
The expiration of the conditional license has no effect on Masivet, an identical AB Science drug sold in Europe that carries the approval of the European Medicines Agency.
FDA issued a “Dear Veterinarian” letter to alert the U.S. profession about Kinavet.
“Kinavet-CA1 is an unapproved animal drug with no legal marketing status,” the letter stated. “You will no longer be able to legally obtain the drug.”
AB Science will alert veterinarians, too.
“As a company that takes its mission very seriously, we plan to be in close contact with not only our veterinary customers but also our distributor partners, all of whom we enjoy a great working relationship with,” Ahn said.
Mast cell canine patients may have other drug options, according to FDA.
“For example, the drug Palladia (toceranib phosphate, NADA 141-295), which is FDA-approved for the treatment of mast cell tumors in dogs, may be appropriate in some cases,” the agency stated. “Also, other FDA-approved animal and human drugs may potentially be used legally in an extralabel manner in dogs with mast cell tumors.”