GAVRETO

批准信原文要点

This Prior Approval sNDA provides for updates to the U.S. Prescribing Information by adding a boxed warning for serious infections, including opportunistic infections, based on analyses from the AcceleRET-Lung study; description of the data informing this safety signal in Section 6.1; and replacement of the Patient Package Insert with Medication Guide labeling.

批准信原文要点

This Prior Approval sNDA provides for revisions to the Hepatic Impairment Sections of the US Prescribing Information to include information based on results from Study GP43163, which was conducted to support the fulfillment of postmarketing requirement 3916-8.

批准信原文要点

This Prior Approval sNDA provides for the conversion from accelerated to regular approval of GAVRETO for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

批准信原文要点

This Prior Approval sNDA provides for removal of the Advanced and Metastatic RET-mutant Medullary Thyroid Cancer (MTC) Indication, approved under accelerated approval, from GAVRETO United States Prescribing Information (USPI).

批准信原文要点

This Prior Approval sNDA provides for updates related to use with (CYP)3A and P-gp inhibitors and CYP3A inducers (Sections 2.4, 2.5, 7.1 and 12.3) in the U.S. Prescribing Information label and Patient Information.

批准信原文要点

This Prior Approval sNDA provides for updates to the U.S. Prescribing Information by adding a boxed warning for serious infections, including opportunistic infections, based on analyses from the AcceleRET-Lung study; description of the data informing this safety signal in Section 6.1; and replacement of the Patient Package Insert with Medication Guide labeling.

批准信原文要点

This Prior Approval sNDA provides for new primary (carton) labeling and updated secondary (container) labeling; and minor formatting and editorial revisions to the US Package Insert and Patient Package Insert.

批准信原文要点

This Prior Approval sNDA provides for revisions to the US Package Insert, Patient Package Insert, and container labels to reflect manufacturer changes from Blueprint Medicines Corporation to Genentech, Inc.; and updates container labels to incorporate the Genentech, Inc. branding design.

批准信原文要点

This new drug application provides for the use of Gavreto (pralsetinib) capsules, 100 mg, for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.