First Oral Treatment for Lymphoma in Dogs Receives FDA's Conditional Approval

Officials with the FDA have conditionally approved verdinexor tablets (Laverdia-CA1; Anivive Lifesciences) to treat dogs with lymphoma. These tablets work to prevent certain proteins from leaving the nucleus of cancer cells, thereby allowing these proteins to control the growth and prevent the spread of cancerous cells in dogs.

Verdinexor is the first conditionally approved oral treatment for dogs with lymphoma, and the second treatment for the condition that the FDA has conditionally approved for dogs. Rabacfosadine for injection (Tanovea-CA1; VetDC) received conditional approval in 2016.

“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,” said Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine, in a prepared statement. “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 allows veterinarians to access needed treatments while the drug company collects additional effectiveness data, such as through trials with client-owned dogs. The company then has up to 5 years to complete effectiveness studies to support a full approval.

The reasonable expectation of effectiveness of verdinexor tablets was established in a study with 58 client-owned dogs with B- or T-cell lymphoma who were followed for at least 8 months. The dogs were either newly diagnosed with lymphoma or were in their first relapse after completing a single or multiagent chemotherapy regimen. The study included dogs of varying breeds, weights and both genders, with the majority of the dogs having lymphoma stage III. Seventeen of the 58 dogs (29%) did not show progression of lymphoma for at least 56 days after taking verdinexor. Three of these dogs did not show any progression for at least 182 days.

The most common adverse reactions associated with verdinexor were anorexia, vomiting, diarrhea, weight loss, lethargy, increased water intake, increased urination, elevated liver enzymes, and low platelet count.

Verdinexor tablets are available only by prescription, and can be administered at home. These tablets are given orally twice per week, with at least 72 hours between doses, and can be administered at home. These tablets should be given to dogs immediately after eating, as this increases the amount of drug absorbed into the bloodstream.

The package insert for prescribing veterinarians includes detailed user safety information and special instructions for handling and administering the drug. Gloves tested for use with chemotherapy drugs should always be worn when handling verdinexor tablets and cleaning up after a dog undergoing treatment and for 3 days following the last treatment. This includes handling the dog’s food and water bowls, as well as feces, urine, vomit or saliva from the dog.

Verdinexor tablets also come with a client information sheet for prescribing veterinarians to give to their clients. This sheet is written specifically for dog owners and explains how to safely handle the drug, how to safely clean up after a dog undergoing treatment, and other important safety information.

Pregnant women, women who may become pregnant, nursing women, and children should not handle or administer verdinexor tablets or touch the feces, urine, vomit or saliva of treated dogs.

REFERENCE

FDA conditionally approves first oral tablet to treat lymphoma in dogs [news release]. Silver Spring, MD; January 11, 2021: FDA. Accessed January 11, 2021. https://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-oral-tablet-treat-lymphoma-dogs