FDA conditionally approves first oral canine lymphoma treatment

The US Food and Drug Administration announced today the conditional approval of Laverdia-CA1 (verdinexor tablets) to treat canine lymphoma.

The first conditionally approved oral treatment for dogs with lymphoma, Laverdia-CA1 prevents certain proteins from leaving the nucleus of cancer cells, thus allowing the proteins to control the growth and prevent the spread of cancerous cells. It is the second conditionally FDA-approved treatment for canine lymphoma. (Tanovea-CA1, an injectable, received conditional FDA approval in 2016.) Laverdia-CA1 is administered orally twice a week at home, with at least 72 hours between doses.

“Lymphoma is a devastating cancer in dogs, with few FDA-approved treatments available. This conditional approval provides a much-needed option to treat dogs with lymphoma,” says Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine, in this FDA release. “We are encouraged to see drug companies bring forward applications for products to treat serious diseases, even if they affect relatively small populations.”

Conditional approval, which is an option for drugs intended for minor use in major species, provides veterinarians with access to necessary treatments while the pharmaceutical company gathers additional efficacy data. According to the FDA website, a company has up to 5 years to complete effectiveness studies to support full approval.

Laverdia-CA1’s reasonable expectation of efficacy was demonstrated in a study of 58 client-owned dogs of various breeds, weights, and genders with B- or T-cell lymphoma. All participants were followed for at least 8 months. The dogs were either newly diagnosed with lymphoma or in their first relapse after completing a single- or multi-agent chemotherapy regimen. Most of the dogs had stage III disease (generalized lymph node enlargement).

After verdinexor administration, 17 of the 58 dogs (29%) showed no progression of lymphoma for at least 56 days. Of these dogs, 3 showed no progression for at least 182 days.

The most common adverse reactions associated with verdinexor administration include anorexia, vomiting, diarrhea, weight loss, lethargy, increased water intake, increased urination, elevated liver enzymes, and low platelet count. Laverdia-CA1 should be administered immediately after eating, thus increasing the amount of drug absorbed into the bloodstream. Pregnant women, women who may become pregnant, nursing women, and children should not handle or administer Laverdia-CA1 or touch the feces, urine, vomit, or saliva of treated dogs.

Laverdia-CA1 is available by prescription only. To learn more about this new drug, go here.