Research & Development
The FDA conditionally approves first oral verdinexor tablet to treat lymphoma in dogs
12 January 2021 -

Public health agency The US Food and Drug Administration on Monday announced first ever conditionally approval for Laverdia-CA1 (verdinexor tablets) for the oral treatment of dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system.

The agency granted conditional approval of Laverdia-CA1 to Anivive Lifesciences Inc through the Minor Use/Minor Species pathway.

Laverdia-CA1 is given orally twice per week, with at least 72 hours between doses. Laverdia-CA1 is the second treatment for lymphoma in dogs with conditional approval. Tanovea-CA1, which received conditional approval in 2016, is an injectable drug, added the agency.

Since Laverdia-CA1 is orally administered, the 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.

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.

This study is based on a study of 58 client-owned dogs with B- or T-cell lymphoma who were followed for at least eight months. The study included dogs of varying breeds, weights and both genders, with the majority of the dogs having lymphoma stage III (generalized lymph node enlargement). About 29% did not show progression of lymphoma for at least 56 days after taking verdinexor, concluded the agency.