FDA Grants Replimune Accelerated Approval for $450,000 Melanoma Drug Tudriqev
Updated
Updated · POLITICO · Aug 13
FDA Grants Replimune Accelerated Approval for $450,000 Melanoma Drug Tudriqev
3 articles · Updated · POLITICO · Aug 13
Summary
Accelerated approval lets Replimune market Tudriqev for advanced melanoma patients whose disease progressed on prior treatment, one week after FDA advisers backed the drug.
About 60 days from now, Replimune expects to begin shipping Tudriqev and is rehiring commercial staff it cut earlier this year after the FDA rejected the application for a second time.
A typical course is expected to cost $450,000, and the therapy will be used alongside Bristol Myers Squibb’s Opdivo as an add-on immunotherapy.
FDA reviewers had said before last week’s advisory meeting that the company’s single-arm trial did not clearly show Tudriqev contributed to the observed benefit because it lacked a randomized control arm.
A roughly 400-patient postmarketing trial must now confirm benefit by comparing Tudriqev against physician’s-choice treatment, leaving full approval dependent on stronger survival data.