What’s Involved in Getting Approval for Drugs Used in Treating Cancer in Dogs?

Approval for Drugs Used in Treating Cancer in Dogs
Cancer is a very common disease in the canine population. Consequently, pet owners and veterinarians alike often wonder why there are so few drugs for treating cancer in dogs. The answer is that the process for achieving approval for a medication involves strict parameters on what constitutes a safe and effective treatment. Any owner whose dog is dying from the disease would understandably say that this is unfortunate. However, it is ultimately good for dogs and owners that a drug like TANOVEA™-CA1 (rabacfosadine for injection) is rigorously tested before it can be approved for use by licensed veterinarians.

The Long Road to Making Pet Cancer Drugs Available

The path to approval for a drug, including treating cancer in dogs, is long and arduous. And it varies, depending on the type of cancer and the type of medication. However, in general, it includes these milestones:

Proving it is safe for use in dogs.

The goal in canine cancer research is to develop substances that are not only effective in targeting the disease, but are safe when used according to the label. Like physicians, veterinarians steadfastly abide by the directive to “first, do no harm.”  In order to be used according to the label drugs must prove a full demonstration of safety, with side effects clearly noted and characterized.  Safety information is also documented and reported even well after a drug is approved for commercial use.

Demonstration of effectiveness.

Deciding if a drug should be brought to market isn’t as simple as determining whether or not it “works.” Researchers must have extensive evidence on exactly how well and how often it works before the FDA will even consider their application.  In the animal health world, there are actually two paths for effectiveness – demonstrating a ‘Reasonable Expectation of Effectiveness’, which allows drugs for minor uses (such as certain dog cancers) to be used by veterinarians under a Conditional Approval, and ultimately a ‘Substantial Demonstration of Effectiveness’ for Full Approval.  Regardless of the path for effectiveness, the approval process is essentially the same for all other milestones.

Choosing the proper formulation and setting dosage guidelines.

Will the drug be given by injection, tablet, capsule, or liquid? And how much of the medicine should be prepared and dosed based on the progression of the disease, the weight of the dog, and other factors? Before a drug can be made available to veterinary clinics, all of these issues must be thoroughly studied and the results carefully documented.

Developing a manufacturing process.

In order for a cancer drug to be approved, the company producing it must prove that it has a production process that is reliable, reproducible, sterile, pure and accurate over time. Companies must meet stringent quality standards and demonstrate a well-validated manufacturing process before any new drug can be made available for veterinarian use.

Determining how the medication will be labeled.

A surprising amount of time, effort, and review goes into deciding how a drug should be labeled. The label must include important details like the indication (the disease(s) the drug will treat) and dosage. It also lists known drug interactions, warnings, contraindications (scenarios in which it should not be used), side effects, human and client safety information, and handling requirements, such as if needing refrigeration, or a requirement that it be stored out of direct sunlight.

Developing Drugs That Are as Safe and Effective as Possible

Creating treatments for cancer in dogs that meet the FDA’s rigorous requirements for approval is a very time consuming and resource intensive process. But for people and companies that love dogs, it is very much worth the time and effort. If you have questions about recently approved cancer drugs, such as the conditionally approved TANOVEA™-CA1 (rabacfosadine for injection), don’t hesitate to ask your veterinarian for more information.