January 23, 2017
Authored and Edited by Jon T. Self, Ph.D.; Susan Y. Tull
FDA has shared its current thinking on the topic of cancer drugs and companion animals. For all the details, check FDA’s Guidance for Industry #237, ‘‘Oncology Drugs for Companion Animals.’’
This non-binding guidance is geared toward people treating sick companion animals (e.g., dogs, cats, horses) at home or the vet. The Guidance also discusses best practices for sponsoring/designing new cancer drug studies in companion animals, with an eye toward submitting a NADA.
Treating a sick companion animal at home:
In discussing cancer drugs for pets, FDA stresses human safety, particularly for treatment at home. This focus on pet owners makes sense, since the pet owner will be giving the drug and must also face the inevitable aftermath of chemotherapy (accidental indoor contributions from pets: urine, feces, vomit, and saliva). To help prepare owners to get their pets back on their feet, this Guidance provides full mock-ups of “Client Information Sheets.” One information sheet covers drugs administered orally; the other, by injection.
These handy guides use plain English and walk pet owners through:
Sponsoring cancer drug studies in companion animals for NADAs:
For sponsors of new cancer drug studies who are aiming for NADA submission, the Agency refers to a variety of good practices for study design. Sources to consider include recommendations from FDA’s Center for Veterinary Medicine and several cited CFR sections. But going beyond general guidance from domestic sources, FDA also points to the disease progression criteria developed abroad, including standards from Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO).
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KEY TAKEAWAYS
Give pets a fighting chance
Give pet owners a fair shake
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The FDA welcomes public comment on its guidance documents, both during drafting and after release of final versions. For details on how to submit comments, see 82 FR 40008 (August 23, 2017).
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