TRODELVY

批准信原文要点

This Prior Approval sBLA provides for a new indication for Trodelvy in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 [Combined Positive Score (CPS ≥10)] as determined by an FDA-authorized test.

批准信原文要点

This Prior Approval sBLA provides for a new indication for Trodelvy as a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor based therapy.

批准信原文要点

This Prior Approval sBLA provides for updates to the Prescribing Information and Patient Labeling to add recommendations for the prophylactic use of G-CSF.

批准信原文要点

This Prior Approval sBLA provides for revisions to the full prescribing information and patient package insert to voluntarily withdraw the following indication: TRODELVY for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

批准信原文要点

This Prior Approval supplemental biologics license application provides for a new indication for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

批准信原文要点

This replacement approval letter incorporates the correction of the error. The effective approval date will remain January 5, 2023, the date of the original approval letter. This Prior Approval sBLA provides for the following: Addition of [redacted] to perform the cell-based binding assay for [redacted] lot release and stability testing, sacituzumab govitecan drug substance and drug product stability testing; and [redacted] as an alternate site to release the cell-based binding assay data generated at [redacted]. Addition of [redacted] to perform the cell-based binding and cytotoxicity assays for sacituzumab govitecan drug substance and drug product lot release and stability testing.

批准信原文要点

This Prior Approval sBLA provides for revisions to Section 2.4 (Preparation and Administration) of the Trodelvy United States Prescribing Information (USPI).

批准信原文要点

This Prior Approval supplemental biologics application provides for revisions to Section 2.4 Preparation for Administration of the Prescribing Information as well as the carton/container labeling to update the dilution and administration instructions. Revisions were also made to clarify wording in Section 8.6 Hepatic Impairment and Section 12.3 Pharmacokinetics/Specific Populations.

批准信原文要点

This Prior Approval supplemental biologics license application provides for a new indication for the treatment of adult patients with Locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This indication is approved under accelerated approval based on tumor response rate and duration of response.

批准信原文要点

Prior Approval supplemental biologics application 013 (S-013) provides for a new indication for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Prior Approval supplemental biologics application 005 (S-005) provides for updates to the U.S. package insert to include final progression-free survival and overall survival data results from study IMMU-132-05.

批准信原文要点

Prior Approval supplemental biologics application 005 (S-005) provides for updates to the U.S. package insert to include final progression-free survival and overall survival data results from study IMMU-132-05. Prior Approval supplemental biologics application 013 (S-013) provides for a new indication for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.