The U.S. Food and Drug Administration recently (Jan. 11) conditionally approved Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system.
According to a press release from the FDA, Laverdia-CA1 is the first conditionally approved oral treatment for dogs with lymphoma.
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 five years to complete effectiveness studies to support a full approval.
Because Laverdia-CA1 is orally administered, owners of dogs with a diagnosis of lymphoma, following a veterinarian prescription and safety directions detailed in a client information sheet, can administer this treatment at home.
Laverdia-CA1 is the second treatment for lymphoma in dogs that the FDA has conditionally approved. Tanovea-CA1, which received conditional approval in 2016, is an injectable drug.
Laverdia-CA1 works to prevent certain proteins from leaving the nucleus of cancer cells, allowing these proteins to control the growth and prevent the spread of cancerous cells in dogs.
“Lymphoma is a devastating cancer in dogs, with few FDA-approved treatments available,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine in the press release. “This conditional approval provides a much-needed option to treat dogs with lymphoma.”
The reasonable expectation of effectiveness of Laverdia-CA1 was established in a study with 58 client-owned dogs with B- or T-cell lymphoma who were followed for at least eight months. The dogs were either newly-diagnosed with lymphoma or were in their first relapse after completing a single or multi-agent 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.
Canine lymphoma affects fewer than 70,000 dogs in the U.S. each year.
The FDA granted conditional approval of Laverdia-CA1 to Anivive Lifesciences Inc.
SOURCE U.S. Food and Drug Administration
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