Ariad Expects Narrower Label, Not Withdrawal, For Iclusig Following Halted Study
Company’s terminated EPIC trial in front-line leukemia was a post-marketing requirement under ponatinib’s accelerated approval for second-line treatment, but management believes FDA will favor a restricted label, rather than withdrawal, to address growing concerns about cardiovascular safety.
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Former directors of pharmacovigilance and risk management agree to pay disgorgements and civil penalties in SEC complaints charging them with trading in Ariad stock in advance of FDA announcements about the leukemia drug Iclusig.
Ponatinib received accelerated approval for use in chronic myeloid leukemia and acute lymphoblastic leukemia patients who are resistant or intolerant to prior therapy with tyrosine kinase inhibitors.
Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks
Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.