See an article by Angus Liu at Fierce Biotech, quoting FDA head oncologist Richard Pazdur on new approaches to oncology in vitro diagnostics. Find it here.
For quite a while, FDA has approved drugs "to be used with an approved diagnostic" without naming the diagnostic. Meanwhile, FDA approved diagnostics based on a specific named drug. For example, EGFR drug "Exkivity" is paired on label to a Thermo Fisher test, and the similar EGFR drug "Rybrevant" is paired to a Guardant test.
Fierce Biotech writes,
- [As] FDA oncology chief Richard Pazdur, M.D., sees it, [current] companion diagnostics don’t serve patients that well.
- Existing cancer companion diagnostics are bundled with the specific cancer drugs they’re approved for. But the FDA is looking to get around this one-drug-one-test situation by looking at “minimal performance criteria” of tests, Pazdur said.
- The concept of a minimal performance criteria, Pazdur said, would allow doctors to use any test that meets those standards, rather than having to stick to specific tests. But the idea doesn’t preclude testmakers from developing and selling drug-specific diagnostics, he added.
- The FDA’s medical device regulators are working on a pilot program to implement that proposal, Pazdur said. The director of the Oncology Center of Excellence made the comment during a discussion with FDA Commissioner Robert Califf, M.D., at the Friends of Cancer Research annual meeting on Thursday.
See more at the original open-access artice.