FDA conditionally approves first oral tablet to treat canine lymphoma

The US Food and Drug Administration (FDA) gave conditional approval to an oral tablet developed to treat canine lymphoma.

Canine lymphoma is one of the most common cancers diagnosed in dogs, representing around 7–14% of all diagnosed canine cancers. More than 30 types of canine lymphoma have been identified, and they vary widely in their behavior.

The medication, Laverdia-CA1, manufactured by Anivive Lifesciences, works by preventing certain proteins from leaving the nucleus of cancer cells, which allows those proteins to control the growth of cancerous cells and prevent their spread in dogs.

But while it is among the most commonly diagnosed canine cancers, canine lymphoma still affects fewer than 70,000 dogs in the US each year. This qualifies Laverdia-CA1 for the FDA’s “minor use in a major species” category, and thus is subject to conditional approval.

Laverdia-CA1 is the second treatment for canine lymphoma conditionally approved by the FDA, and the first oral one. Tanovea-CA1, an injectable drug, received conditional approval in 2016.

Conditional versus full approval

Conditional approval and full approval both require that a drug company prove, among other things, that the drug is safe when used according to the label. The difference lies in how effective each needs to be.

Per the FDA, to qualify for full approval, a drug company must provide “substantial evidence of the drug’s effectiveness.” For conditional approval, the drug company must show only that the drug has a “reasonable expectation of effectiveness.”

Conditional approval by the FDA allows a drug company to legally sell an animal drug before proving that it meets the “substantial evidence” standard required for full approval, as well as legally promote and advertise the drug for the labeled use.

Perhaps more importantly, conditional approval allows veterinarians to access needed treatments while the drug company collects additional data on effectiveness, such as through trials with client-owned dogs. The company has up to five years to complete that research in order to obtain full approval.

And because Laverdia-CA1 is orally administered, it’s likely to be of particular interest to clients whose dogs are diagnosed with lymphoma because they can administer the treatment themselves at home—if prescribed by their veterinarian and while following safety directions detailed in a client information sheet.

Laverdia-CA1 is administered orally twice per week, with at least 72 hours between doses.

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