Tuesday , January 19 2021

The FDA has tentatively approved the first oral treatment for dogs with lymphoma



Today, the US Food and Drug Administration conditionally approved Laverdia-CA1 (Verdinexor tablets) for the treatment of dogs with lymphoma, lymph node and lymphatic cancer. Laverdia-CA1 works to prevent the release of certain proteins from the nucleus of cancer cells, thereby allowing these proteins to control the growth and prevent the spread of cancer 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 diagnosed with lymphoma can follow this treatment at home, following the veterinarian’s prescription and safety instructions detailed in the client’s information sheet. Laverdia-CA1 is given orally twice a week, with at least 72 hours between doses. Laverdia-CA1 is the second FDA-approved treatment for lymphoma in dogs. Tanovea-CA1, which received conditional approval in 2016, is an injectable drug.

Lymphoma is a devastating cancer in dogs, and there are several FDA-approved treatments. This conditional approval provides a much-needed treatment option for dogs with lymphoma. We are invited to see how pharmaceutical companies apply for products to treat serious diseases, even if they affect a relatively small population. “

Stephen M. Solomon, DVM, MPH, Director of the FDA Center for Veterinary Medicine

Conditional approval allows veterinarians to access the necessary treatments, while the pharmaceutical company collects additional efficacy data, for example, during trials with client-owned dogs. The company then has up to five years to complete a performance study to support full approval.

Reasonable reliance on the efficacy of Laverdia-CA1 was established in a study of 58 dogs belonging to clients with B- or T-cell lymphoma who were observed for at least eight months. The dogs had recently been diagnosed with lymphoma (not yet), or had their first relapse after a single or multi-agent chemotherapy regimen. The study included dogs of different breeds, weights, and both sexes, with most dogs having stage III lymphoma (generalized lymph node enlargement). Seventeen of 58 dogs (29%) did not show lymphoma progression for at least 56 days after taking verdinexor. Three of these dogs did not progress 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 enzymes, and low platelet counts. Laverdium-CA1 should be given to dogs immediately after a meal, as it increases the amount of drugs absorbed into the blood.

The package insert for veterinary prescriptions contains detailed information on user safety and special instructions for handling and administration of the drug. Always wear gloves tested for use with chemotherapeutic agents when working with Laverdia-CA1 and cleaning up after the treated dog and for three days after the last treatment. This includes handling bowls for food and water, as well as feces, urine, vomit or saliva from the dog. Laverdia-CA1 also comes with client information for veterinary appointments to its clients. This sheet is specifically written for dog owners and explains how to safely handle Laverdia-CA1, how to safely clean up after a dog has passed, and other important safety information.

Pregnant women, women who may become pregnant, and nursing women should not handle or administer the drug or touch the feces, urine, vomit, or saliva of treated dogs. Children should also not touch Laverdia-CA1 or the feces, urine, vomit or saliva of treated dogs.

Laverdia-CA1 is available only on prescription due to the professional experience required to diagnose canine lymphoma, provide adequate post-treatment care instructions and monitor the safe use of the drug, including the treatment of any adverse reactions.

Laverdia-CA1 has been conditionally approved through the minor / minor species route, which is an option for drugs intended for minor use in major species (dogs, cats, horses, cattle, pigs, turkeys and chickens) or for minor species. Canine lymphoma affects less than 70,000 dogs in the United States each year, and therefore qualifies as minor use in major species.

The FDA has granted Laverdia-CA1 conditional approval to Anivive Lifesciences Inc.

Source:

US Food and Drug Administration


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