ENHERTU

批准信原文要点

These Prior Approval sBLAs provide for two separate indications: • ENHERTU followed by a taxane, trastuzumab, and pertuzumab (THP) is indicated for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer as determined by an FDA-authorized test; • ENHERTU is indicated for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment.

批准信原文要点

These Prior Approval sBLAs provide for two separate indications: • ENHERTU followed by a taxane, trastuzumab, and pertuzumab (THP) is indicated for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer as determined by an FDA-authorized test; • ENHERTU is indicated for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment.

批准信原文要点

This Prior Approval sBLA provides for updates to the U.S. Prescribing Information labeling based on updated clinical efficacy and safety data from Study DESTINY-Lung02 (DL-02; DS8201-A-U206) after longer follow-up.

批准信原文要点

Prior Approval sBLA S-038 proposes a new indication for Enhertu in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.

批准信原文要点

Prior Approval sBLA S-038 proposes a new indication for Enhertu in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.

批准信原文要点

Prior Approval sBLA 032 provides for adding the following new indication to the USPI: Enhertu is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.

批准信原文要点

provides for adding the following new indication to the USPI: Enhertu is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting

批准信原文要点

This Prior Approval supplemental biologics license application provides for the use of Enhertu for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

批准信原文要点

This Prior Approval supplemental biologics license application provides for updated overall survival data from DESTINY-Breast03 and to provide results from DESTINY-Breast02. This supplement also provides revised labeling to fulfill PMC 4269-1 from May 4, 2022, approval letter for BLA 761139/S-017 and S-020.

批准信原文要点

This Prior Approval supplemental biologics license application provides for revisions to Section 1.2 (Indications and Usage) and 14.2 (Clinical Studies) of the labeling to include the use of PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay as a companion diagnostic device for fam-trastuzumab deruxtecan-nxki for assessment of “HER2- low” status.

批准信原文要点

This Prior Approval sBLA provides for the use of ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have an activating HER2 (ERBB2) mutation, as detected by an FDA-approved test, and who have received a prior systemic therapy.

批准信原文要点

This corrected action letter incorporates the correction of the error. This Prior Approval supplemental biologics license application provides for regular approval of ENHERTU for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer...

批准信原文要点

Supplement 020: Provides for modification of the breast cancer indication from: ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. ... to the following: ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either: in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

批准信原文要点

Supplement 017: Provides for regular approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

批准信原文要点

This Prior Approval supplemental biologics application provides for a new indication for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.