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Oncologic Drugs Advisory Committee – TARIUS – GLOBAL REGULATORY REQUIREMENTS
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Oncologic Drugs Advisory Committee

December 2

The committee will hear updates on new drug applications (NDAs) approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) that have not verified clinical benefit. Specifically, the committee will receive updates on the following products: (1) NDA 205353, FARYDAK (panobinostat) capsules, submitted by Secura Bio, Inc., indicated in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent and (2) NDA 202497, MARQIBO (vincristine sulfate LIPOSOME injection) for intravenous infusion, submitted by Acrotech Biopharma LLC, indicated for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.

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Date:
December 2
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