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# Panel to Discuss 2 Accelerated Approval NDAs
- URL: https://www.fdaweb.com/panel-to-discuss-2-accelerated-approval-ndas/
- Published: 2021-09-23T12:00:00.000Z
- Updated: 2026-09-14T17:15:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150205

*Federal Register* notice: FDA has announced a 12/2 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to hear certain updates on NDAs approved under accelerated approval that have not verified clinical benefit. Products being discussed are: **(1)** Secura Bio’s Farydak (panobinostat) capsules, indicated in combination with bortezomib and dexamethasone for treating patients with multiple myeloma who have received at least two prior regimens, and **(2)** Acrotech Biopha’s Marqibo (vincristine sulfate liposome injection) for intravenous infusion, indicated for treating adult patients with Philadelphia chromosome negative-acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-20740.pdf?ref=fdaweb.com).