Karyopharm canine lymphoma treatment approved
Karyopharm Therapeutics has received conditional approval from the U.S. Food and Drug Administration for Verdinexor, its oral treatment of canine lymphoma.
The Natick-based company said Monday that preliminary data indicated Verdinexor could halt disease progression in most dogs and induce tumor shrinkage in one-third of cases. It has also been shown to work in both new and relapsed cases of lymphoma, said Dr. Cheryl London, lead investigator on the most recent trial.
“Verdinexor represents a novel oral therapy that can be given by owners at home, providing an alternative … that may allow many more dogs access to treatment for their lymphoma,” Dr. Sharon Shachman, Karyopharm’s founder and president, said in a statement.
Karyopharm said current canine lymphoma treatments require weekly veterinary visits for chemotherapy injections, which are not feasible for many dog owners. No new canine lymphoma drugs have been approved in more than two decades, the company said.
In addition, the drug’s “minor use” designation qualifies it for benefits similar to those for orphan drugs used to treat humans. Orphan drug benefits include an accelerated approval process, market exclusivity and tax credits for certain trials.
Karyopharm said it plans to work with a marketing partner to complete the final section of its application, which covers commercial-scale manufacturing of the drug. As part of the current conditional approval, Karyopharm must conduct a full, often randomized study within five years to confirm Verdinexor’s effectiveness.
(Image credit: freedigitalphotos.net)
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