FDA “Available Therapy” Determination Is A Moving Target, Industry Groups Say
In comments on the agency’s expedited programs draft guidance, PhRMA and BIO say a decision about the relevant standard of care is needed earlier in the development process; groups call for more flexibility on accelerated approval than is suggested in the guidance and identify several issues involving breakthrough therapies that need more clarity.
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Agenus was banking on US FDA taking the full six months to act on Keytruda application in same cervical cancer indication where it was seeking accelerated approval; agency took less than two months, making it among the fastest oncology supplemental approvals in the last two years.
Sponsors of ‘breakthrough therapy’-designated investigational oncology products may need to identify a niche subpopulation that remains underserved when a competing product with accelerated approval in the same indication completes confirmatory trials.
Attorneys Sasinowski and Varond write that in some cases weak clinical evidence on the surrogate endpoint was not a barrier, but strong findings on unmet need and rarity usually are necessary for accelerated approval.