AB Science's Kinavet cancer drug for dogs loses FDA marketing authorization

France's AB Science suffered another setback in its years-long effort to gain traction for its lead compound, masitinib, which it has been developing for both veterinary and human medicine. The company has been selling a version of the drug, called Kinavet, to treat mast cell tumors in dogs for the last 5 years under a conditional approval from the FDA, but on Dec. 15 the agency announced that the marketing license was no longer in effect. The reason? AB Science missed its deadline for providing data to the FDA required to obtain full approval. AB has a study underway in 150 dogs, and an interim analysis "showed statistically significant superiority" over placebo in the time it took for the skin cancer to progress, according to a press release from the company. AB is collaborating with the FDA to finish the study and gain full approval for the product next year, it added. The drug remains on the market in Europe, where it sells under the brand name Masivet. AB said it does not expect the loss of U.S. Kinavet sales to affect its financial results, since the product had only reached the break-even point. Release

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