FDA conditionally approves first drug for treating lymphoma in dogs
The U.S. Food and Drug Administration announced the conditional approval of Tanovea-CA1 (rabacfosadine for injection) on Jan. 3, the first new animal drug intended to treat canine lymphoma.
Tanovea-CA1, which comes in a concentrated form, is diluted and given intravenously for 30 minutes. The infusion should be given by or under the supervision of a veterinarian experienced in chemotherapy. According to Doug Thamm, VMD, a cancer researcher who led clinical trials at Colorado State University’s Flint Animal Cancer Center, Tanovea-CA1 provides a different treatment option. Than other drugs. Doses are given every three weeks, for a total of five infusions. This is in contrast to conventional chemotherapy treatments that require up to 16 weekly visits.
Tanovea-CA1’s conditional approval means that when used according to the label, the drug is safe and has a “reasonable expectation of effectiveness” for treating lymphoma in dogs. The conditional approval allows the drug manufacturer, VetDC, Inc., to legally sell Tanovea-CA1 before proving it meets the “substantial evidence” standard of effectiveness for full approval. The conditional approval is valid for one year, and VetDC, Inc. can continue applying for conditional approval annually until they reach a total of five years of conditional approval.
Thamm, at CSU, was positive about the approval. “Across the board, we saw some positive activity in up to 80 percent of all the lymphoma patients that were treated with this medication,” he said in a campus release.
The FDA is providing additional resources for Tanovea CA1’s conditional approval. These include the following web pages:
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