Treats locally advanced or metastatic non-small cell lung cancer (NSCLC) with a…. NDA 213246, held by Eli Lilly And Co. Selpercatinib.
As of Nov 13, 2026, NDA 213246 (Retevmo), held by Eli Lilly And Co, was first approved by FDA on May 8, 2020, with 12 approved supplements and 0 published complete response letters.
RETEVMO is a kinase inhibitor indicated 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 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 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 (if radioactive iodine is appr…
| Jul 14, 2026 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Nov 20, 2025 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Sep 27, 2024 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Sep 27, 2024 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2024 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| May 29, 2024 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Sep 21, 2022 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Sep 21, 2022 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| May 8, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Retevmo40MG · capsule;oral | Selpercatinib | RxReference drug |
| Retevmo80MG · capsule;oral | Selpercatinib | RxReference drug |
| Jul 14, 2026 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Nov 20, 2025 | Supplement 16Labeling · Standard review | Approved | |
| Nov 20, 2025 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2024 | Supplement 14Labeling · Standard review | Approved | |
| Sep 27, 2024 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Sep 27, 2024 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2024 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| May 29, 2024 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Apr 10, 2024 | Supplement 10Labeling · Standard review | Approved | |
| Sep 21, 2022 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Sep 21, 2022 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2021 | Supplement 2Labeling · Standard review | Approved | |
| May 8, 2020 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
