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# Oncologic Panel to Review 4 Cancer Submissions
- URL: https://www.fdaweb.com/oncologic-panel-to-review-4-cancer-submissions/
- Published: 2025-05-07T12:00:00.000Z
- Updated: 2026-09-14T15:11:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159138

FDA is [announcing](https://public-inspection.federalregister.gov/2025-08060.pdf?ref=fdaweb.com) a two-day (5/20-21) Oncologic Drugs Advisory Committee meeting to review and vote on four cancer drug submissions. During the morning session on 5/20, panel members will discuss a supplemental BLA for Genentech’s Columvi (glofitamab) injection and its use in combination with gemcitabine and oxaliplatin for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant (ASCT). In the afternoon on 5/20, they will discuss a Janssen Biotech supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase) injection and its use as monotherapy for treating adult patients with high-risk smoldering multiple myeloma.

On 5/21, the morning session will discuss a UroGen Pharma NDA for mitomycin intravesical solution for treating adult patients with low-grade intermediate-risk non-muscle invasive bladder cancer. The afternoon session will discuss a Pfizer supplemental NDA for Talzenna (talazoparib) capsules and its use in combination with enzalutamide for treating adult patients with metastatic castration-resistant prostate cancer.