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# Panel to Discuss Certain Accelerated Approvals
- URL: https://www.fdaweb.com/panel-to-discuss-certain-accelerated-approvals/
- Published: 2022-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:52:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152316

*Federal Register* notice: FDA has announced a 9/22-23 Oncologic Drugs Advisory Committee meeting. On 9/22, panel members will discuss a Spectrum Pharmaceuticals NDA for poziotinib tablets, indicated for treating patients with previously treated, locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations. They will also discuss the next steps for Oncopeptides’ Pepaxto (melphalan flufenamide) indicated for combination use with dexamethasone for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. The drug was approved under the accelerated approval program, but a recent confirmatory trial demonstrated a worse overall survival and failed to verify clinical benefit. And on 9/23, the panel will discuss an updated benefit-risk profile of Secura Bio’s Copiktra (duvelisib) capsules and its use in treating adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies. Late last month, FDA warned about a possible increased risk of death with Copiktra. A [Drug Safety Communication](https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-possible-increased-risk-death-and-serious-side-effects-cancer-drug-copiktra?utm%5Fmedium=email&utm%5Fsource=govdelivery) said the risk was seen in results from a clinical trial that also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-15609.pdf?ref=fdaweb.com).