Advisory Committee; Oncologic Drugs Advisory Committee; Renewal

Inc. The proposed indication (use) is for the treatment of adult patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The issues the Committee discussed focused on whether randomized trialsshould be required in the future to assess the effectiveness oftherapies in LG-IR-NMIBC given the uncertainty regarding interpretation of study results. The Committee was split with a slight majority voting that the overall benefit-risk of UGN-102 was not favorable in patients with recurrent LG-IR-NMIBC (5 Noes and 4 Yeses). Agency Action: The Agency is reviewing recommendations made at the meeting. On the afternoon of May 21, 2025, the Committee discussed supplemental new drug application (sNDA) 211651/S-013, for TALZENNA (talazoparib) capsules, submitted by Pfizer Inc. The proposed indication (use) is in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The issues the Committee discussed focused on whether efficacy should be formally evaluated in a biomarkernegative population when the biomarker is predictive of response and the prevalence of the biomarker-negative group is high. The Committee members were in unanimous agreement (8 Noes, and 0 Yeses) that the results from the TALAPRO-2 trial were not sufficient to conclude a favorable benefit- risk profile for adding talazopa