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# Novartis Gets Full Approval for Tabrecta
- URL: https://www.fdaweb.com/novartis-gets-full-approval-for-tabrecta/
- Published: 2022-08-11T12:00:00.000Z
- Updated: 2026-09-14T17:55:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152495

FDA has granted full approval to Novartis for its previously accelerated-approved Tabrecta (capmatinib) for treating adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping (as detected by an FDA-approved test).

Accelerated approval was gained 5/2020 based on the therapy’s overall response rate (ORR) and duration of response (DOR) in the GEOMETRY mono-1 trial (NCT02414139). “The conversion to regular approval was based on data from an additional 63 patients, as well as an additional 22 months of follow- up time to assess durability of response and verify clinical benefit,” an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capmatinib-metastatic-non-small-cell-lung-cancer/?ref=fdaweb.com) says. In 60 treatment-naïve patients, ORR was 68% and DOR was 16.6 months. Among 100 previously treated patients, ORR was 44% and DOR was 9.7 months.

The most common adverse reactions seen in more than 20% of patients were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite, the agency says.