RETEVMO

批准信原文要点

These Prior Approval sNDAs provide for conversion from accelerated approval to traditional approval of Retevmo (selpercatinib) for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion

批准信原文要点

These Prior Approval sNDAs provide for a request for pediatric exclusivity in response to the June 22, 2023, Pediatric Written Request, and provides pediatric safety and efficacy updates (section 14 CLINICAL STUDIES) of the U.S. Prescribing Information labeling. Additional updates include alternative administration instructions for patients unable to swallow capsules or tablets, edits to Section 5.6 (Hypersensitivity in WARNINGS AND PRECAUTIONS), dose modifications for hypersensitivy reactions, safety findings of Stevens Johnson Syndrome in post-marketing experience, and the addition of patient Instructions for Use (IFU) labeling.

批准信原文要点

provides pediatric safety and efficacy updates (section 14 CLINICAL STUDIES) of the U.S. Prescribing Information labeling. Additional updates include alternative administration instructions for patients unable to swallow capsules or tablets

批准信原文要点

This Prior Approval sNDA provides for revisions to the DRUG INTERACTIONS (7.2 Effects of Retevmo on Other Drugs) and CLINICAL PHARMACOLOGY (12.3 Pharmacokinetics) sections of the U.S. Prescribing Information labeling, with updates on BCRP substrates based on a completed drug-drug interaction study

批准信原文要点

conversion from accelerated approval to traditional approval of Retevmo (selpercatinib) for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation

批准信原文要点

conversion from accelerated approval to traditional approval of Retevmo (selpercatinib) for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.

批准信原文要点

This Prior Approval sNDA provides for conversion to traditional approval of Retevmo capsules for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory

批准信原文要点

This “Prior Approval” sNDA supports approval for the use of selpercatinib in pediatric patients 2 years of age and older with RET-activated solid tumors and to include interim efficacy and safety results from Study LIBRETTO-121 in the US Product Insert.

批准信原文要点

This Prior Approval sNDA amends the selpercatinib capsule labeling to include information on selpercatinib tablets submitted under NDA 218160.

批准信原文要点

This “Prior Approval” sNDA provides for use of RETEVMO (selpercatinib) capsules, for oral use for adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

批准信原文要点

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

批准信原文要点

This Prior Approval supplemental new drug application provides for additions and revisions to the following sections of the package insert, which also includes results from renal impairment study LOXO-RET-18023...