FDA Grants Accelerated Approval to Capmatinib for NSCLC

The FDA granted accelerated approval to capmatinib for adult patients with metastatic non-small cell lung cancer.

The FDA granted accelerated approval to capmatinib (Tabrecta) for 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.1

In addition, the FDA also granted approval to the FoundationOne CDx assay as a companion diagnostic for capmatinib. 

“With NSCLC, understanding whether a mutation is driving the cancer is critical, and it’s important for doctors and patients to use comprehensive biomarker testing at the time of diagnosis or progression to check for mutations like those that cause METex14,” Andrea Ferris, president and chief executive officer of LUNGevity, said in a press release.“Knowing more about the molecular makeup of their tumor will help patients and their healthcare teams make informed treatment-related decisions from the start.”

Efficacy for capmatinib was demonstrated in the multicenter, non-randomized, open-label, multi-cohort phase II GEOMETRY mono-1 trial, designed to evaluate the agent in 97 patients with metastatic NSCLC with confirmed METexon 14 skipping. Trial participants were given 400 mg of capmatinib orally twice daily until disease progression or unacceptable toxicity.

The primary outcome measure was overall response rate (ORR) determined by a blinded independent review committee using RECIST 1.1. Secondary outcome measures included duration of response (DOR), time to response, disease control rate, progression-free survival, and overall. 

Of 28 treatment-naïve patients, the ORR was 68% (95% CI, 48-84) with a DOR of 12.6 months (95% CI, 5.5-25.3). Moreover, of the 69 patients who were previously treated, the ORR was 41% (95% CI, 29-53) with a DOR of 9.7 months (95% CI, 5.5-13.0). 

“Non-small cell lung cancer is a complex disease, with many different possible mutations that may encourage the cancer’s growth,” Juergen Wolf, MD, from the Center for Integrated Oncology at University Hospital Cologne and lead investigator of the GEOMETRY study, said in a press release. “METexon 14 skipping is a known oncogenic driver. With today’s decision by the FDA, we can now test for and treat this challenging form of lung cancer with a targeted therapy, offering new hope for patients with NSCLC harboring this type of mutation.”

The most common adverse eventswere peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. Further, capmatinib has also been known to cause interstitial lung disease, hepatotoxicity, photosensitivity, and embryo-fetal toxicity.

The FDA recommended a dose of 400 mg orally twice daily with or without food. 

The agency noted that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 


1. FDA. FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer. FDA website. Published May 6, 2020. fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-capmatinib-metastatic-non-small-cell-lung-cancer. Accessed May 6, 2020.

2. Novartis announces FDA approval of MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14 [news release]. Basel. Published May 6, 2020. globenewswire.com/news-release/2020/05/06/2028748/0/en/Novartis-announces-FDA-approval-of-MET-inhibitor-Tabrecta-for-metastatic-non-small-cell-lung-cancer-with-METex14.html. Accessed May 6, 2020.