March 01, 2021
FDA gives conditional approval to canine lymphoma drug
An oral-administration treatment for canine lymphoma gained conditional approval Jan. 11.
The Food and Drug Administration’s decision allows sales of verdinexor tablets—under the name Laverdia-CA1—while the drug’s sponsor, Anivive Lifesciences Inc., collects more efficacy data. Evidence provided by the company provided reasonable assurance the drug will be effective, an agency announcement states.
In one study, Anivive Lifesciences administered Laverdia-CA1 to 58 client-owned dogs with B- or T-cell lymphoma. The summary and the FDA announcement indicates 17 of the dogs—29%—showed improvement or no further progression of their lymphoma in the eight weeks after treatment began, and three had no disease progression for 26 weeks.
The summary also indicates 19 of the dogs had at least 30% reductions in the size of target lesions and one dog’s lymph nodes returned to a normal, nonpathogenic size.
Agency officials see potential that Laverdia-CA1 could be administered by pet owners at home, although any caregivers handling the drug should wear gloves rated for handling chemotherapeutics. Caregivers also should wear such gloves in the three days after administration when handling the dog’s food and water bowls or cleaning up its feces, vomit, urine, or saliva.
The agency also warns against any handling of the drug, a patient’s waste, or a patient’s bodily fluids by children and by women who are pregnant or nursing or likely to become pregnant.
The agency granted the conditional approval through the Minor Use/Minor Species regulatory pathway, which lets companies sell treatments for uncommon conditions while completing studies for full approval. For dogs, the minor-use rules apply to conditions affecting fewer than 70,000 patients annually.
Drug sponsors have five years to complete the remaining studies, and they must show progress each year, FDA information states. The “CA1” suffix means the product is the first conditionally approved application of a drug.
In the announcement, Dr. Steven M. Solomon, director of the FDA Center for Veterinary Medicine, said lymphoma is a devastating cancer in dogs with few approved treatments.
Another company, VetDC Inc., received conditional approval in December 2016 for its injection-administered rabacfosadine product, Tanovea-CA1. Prior to that conditional approval, the only drugs available to treat canine lymphoma were drugs approved for use in humans, FDA information states.