Treats metastatic non-small cell lung cancer (NSCLC). NDA 213591, held by Novartis Pharm. Capmatinib Hydrochloride.
As of Nov 13, 2026, NDA 213591 (Tabrecta), held by Novartis Pharm, was first approved by FDA on May 6, 2020, with 4 approved supplements and 0 published complete response letters.
TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 2022 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| May 6, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TabrectaEQ 150MG BASE · tablet;oral | Capmatinib Hydrochloride | RxReference drug |
| TabrectaEQ 200MG BASE · tablet;oral | Capmatinib Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2024 | Supplement 11Labeling · Standard review | Approved | |
| Mar 24, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Aug 10, 2022 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jan 21, 2022 | Supplement 2Labeling · Standard review | Approved | |
| May 6, 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
