The U.S. Food and Drug Administration today conditionally approved Laverdia-CA1 (verdinexor tablets) for the treatment of dogs with lymphoma, a type of cancer of the lymph nodes and the lymphatic system. Laverdia-CA1 works to prevent some proteins from leaving the nucleus of cancer cells, thus allowing these proteins to control growth and prevent the spread of cancerous cells in dogs.
Laverdia-CA1 is the first conditionally approved oral treatment for dogs with lymphoma. Because Laverdia-CA1 is administered orally, owners of dogs with a diagnosis of lymphoma, following a veterinary prescription and safety instructions outlined in a consumer information leaflet, can administer this treatment. passed at home. Laverdia-CA1 is given orally twice a week, with at least 72 hours between doses. Laverdia-CA1 is the second treatment for lymphoma in dogs that is FDA approved with conditions. Tanovea-CA1, which was licensed with conditions in 2016, is an injectable drug.
Lymphoma is a devastating cancer in dogs, with very few FDA-approved treatments available. This conditional agreement provides a much-needed option for treating dogs with lymphoma. We are encouraged to see drug companies bring forward claims for products to treat serious diseases, even if they affect relatively small numbers. “
Steven M. Solomon, DVM, MPH, Director, FDA Center for Medical Medicine
A condition license allows veterinarians to access the required treatments while the drug company collects additional efficacy data, such as through trials with consumer-owned dogs. The company then has up to five years to complete efficiency audits to support full licensing.
The reasonable expectation of Laverdia-CA1 efficacy was established in a study of 58 dogs with users with B- or T-cell lymphoma that was followed for at least eight months. The dogs were either re-diagnosed with lymphoma (naïve) or were in the first relapse after completing a single or multi-agent chemotherapy regimen. The study included dogs of different breeds, weights and all sexes, with the majority of dogs with stage III lymphoma (generalized lymph node enlargement). Seventeen of the 58 dogs (29%) did not show lymphoma progression for at least 56 days after taking verdinexor. Three of these dogs showed no improvement for at least 182 days.
The most common side effects associated with verdinexor were anorexia, vomiting, diarrhea, weight loss, lethargy, increased water intake, increased urination, elevated liver enzyme, and low platelet count. Dogs should be given Laverdia-CA1 immediately after eating, as this increases the amount of drug absorbed into the bloodstream.
The prescription package for prescribing veterinarians includes detailed information on consumer safety and specific instructions for handling and dispensing the drug. Gloves that have been tested for use with chemotherapy drugs should always be worn when handling Laverdia-CA1 and cleaning after your dog has received treatment and for three days after treatment finally. This includes handling the dog’s bowls of food and water, as well as feces, urine, vomit or saliva from the dog. Laverdia-CA1 also comes with a consumer information sheet for veterinarians to prescribe to their clients. This page is written specifically for dog owners and explains how to handle Laverdia-CA1 safely, how you can safely clean up after your dog undergoes treatment and other important safety information.
Pregnant women, potentially pregnant women, and nursing women should not handle or administer the drug or rub on feces, urine, vomit or saliva of treated dogs. Children should also not rub Laverdia-CA1 or treat feces, urine, vomit or saliva of dogs.
Laverdia-CA1 is only available by prescription due to the professional experience required to diagnose canine lymphoma, provide appropriate guidance for postoperative care, and monitor the safe use of the product, which including the treatment of any adverse effects.
Laverdia-CA1 has received conditional approval through the Minority / Minor Species route, which is an option for drugs intended for minor use in key species (dogs, cats, horses, cattle, pigs, turkeys and chickens) or for minor species. Canine lymphoma affects less than 70,000 dogs in the U.S. each year, and as such, it deserves a minor use in a major breed.
The FDA approved Laverdia-CA1 terms to Anivive Lifesciences Inc.
Source:
U.S. Food and Drug Administration