FDA Grants Full Approval of Laverdia

Approval Granted With Minor Use/Major Species (MUMS) Pathway

The U.S. Food and Drug Administration has granted full approval to Laverdia® (verdinexor tablets), the first FDA-approved oral treatment for lymphoma in dogs. Canine lymphoma is a cancer of the lymph nodes and lymphatic system and represents one of the most diagnosed malignancies in dogs.

Laverdia works by preventing specific regulatory proteins from leaving the nucleus of cancer cells, allowing those proteins to exert their normal growth-control functions and limiting the spread of cancerous cells.

The drug is administered orally by pet owners at home, following a veterinarian’s prescription and detailed safety instructions.

Prescription Use and Administration

Laverdia is available by prescription only, reflecting the clinical expertise required to diagnose canine lymphoma, develop and oversee an appropriate treatment plan, and monitor for adverse reactions and treatment response.

The medication is administered twice weekly, with at least 72 hours between doses, and should be given immediately after a dog eats to improve absorption into the bloodstream.

Regulatory Pathway: Minor Use in a Major Species

Laverdia was conditionally approved in January 2021 under the FDA’s Minor Use/Minor Species (MUMS) pathway. While dogs are considered a major species, canine lymphoma affects fewer than 80,000 dogs annually in the U.S., qualifying the indication as a minor use.

The MUMS pathway is intended to encourage development of treatments for less common diseases, address unmet veterinary medical needs, and allow earlier access to therapies while effectiveness data are being completed.

Conditional approvals are granted for one year at a time, with the possibility of up to four annual renewals, provided the sponsor demonstrates active progress toward generating substantial evidence of effectiveness.

After four renewals, the drug’s sponsor, Anivive Lifesciences, Inc., submitted the required clinical data to support full FDA approval.

Safety and Handling Requirements

Because Laverdia is a chemotherapy agent, the FDA requires enhanced user safety measures for pet owners and caregivers. The prescribing information includes detailed handling instructions, and veterinarians are required to provide a client information sheet written specifically for dog owners.

Key safety requirements include medical gloves approved for chemotherapy use must be worn when handling the drug. Gloves must also be worn when cleaning up feces, urine, vomit, saliva, food bowls, and water bowls from treated dogs. These precautions apply during treatment and for three days after the final dose.

Certain individuals should not handle the medication or exposed materials, including pregnant women, women who may become pregnant, nursing women, and children

These safeguards are designed to protect human health while allowing effective at-home treatment for dogs.

Why This Approval Matters

Laverdia’s full approval represents a milestone in oral oncology treatments for companion animals, successful use of the MUMS conditional approval framework to address a serious disease, and a clear example of how FDA balances access, safety, and scientific rigor in veterinary drug regulation.

For veterinarians, manufacturers, and animal health stakeholders, this case illustrates how targeted regulatory pathways can support innovation while maintaining accountability and post-approval oversight.

Read the FDA announcement here.