HEALTH - Canine Cancer Drug Taken Off the Market

Oasmia Pharmaceutical AB has taken a canine cancer drug, Paccal Vet, or paclitaxel for injection, off the market to study lowering the dose to reduce adverse effects.

Paccal Vet had been conditionally approved by the FDA for the treatment of:

• Non-resectable stage III, IV or V mammary carcinoma in dogs that have not received previous chemotherapy, or radiotherapy.
• Resectable and non-resectable squamous cell carcinoma in dogs that have not received previous chemotherapy, or radiotherapy.

To receive a conditional approval from the FDA, a drug company must prove, among other things, that the animal drug is safe and has a “reasonable expectation of effectiveness” when used according to the label for the proposed conditionally-approved use.

Conditional approval allows the drug company to legally market the animal drug for up to five years.

During this period, the company develops and submits to the FDA the necessary data to prove that the drug meets the “substantial evidence” standard of effectiveness for full approval.

Paccal Vet-CA1 had been available to a limited number of oncology specialists and veterinarians are now being told to stop using the drug.

Oasmia anticipates that lowering the dose to reduce side effects and improve comfort for companion animals will make the product far more attractive to veterinarians and pet owners.

Paclitaxel has been used in the treatment of people with breast, lung, prostate and other cancers.