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FDA Grants Accelerated Approval to Capmatinib for Metastatic NSCLC

FDA also approved a companion diagnostic for capmatinib
07 May 2020
Anticancer agents & Biologic therapy;  Lung and other thoracic tumours;  Personalised medicine

On 6 May 2020, the US Food and Drug Administration (FDA) granted accelerated approval to capmatinib (TABRECTA, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

FDA also approved the FoundationOne CDx assay (Foundation Medicine, Inc.) as a companion diagnostic for capmatinib.

Efficacy was demonstrated in the GEOMETRY mono-1 trial (NCT02414139), a multicentre, non-randomised, open-label, multicohort study enrolling 97 patients with metastatic NSCLC with confirmed MET exon 14 skipping. Patients received capmatinib 400 mg orally twice daily until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate (ORR) determined by a blinded independent review committee using RECIST v1.1 and response duration. Among the 28 treatment-naïve patients, the ORR was 68% (95% confidence interval [CI] 48, 84) with a response duration of 12.6 months (95% CI 5.5, 25.3). Among the 69 previously treated patients, the ORR was 41% (95% CI 29, 53) with a response duration of 9.7 months (95% CI 5.5, 13.0).

The most common adverse reactions (≥ 20% of patients) were peripheral oedema, nausea, fatigue, vomiting, dyspnoea, and decreased appetite. Capmatinib can also cause interstitial lung disease, hepatotoxicity, photosensitivity, and embryo-foetal toxicity.  Based on a clear positive signal for phototoxicity in early laboratory studies in cells, patients may be more sensitive to sunlight and should be advised to take precautions to cover their skin, use sunscreen, and not tan while taking capmatinib.

The study results were reported at AACR 2020 Virtual Meeting I.

The recommended capmatinib dose is 400 mg orally twice daily with or without food.

Full prescribing information for TABRECTA is available here.

This indication is approved under accelerated approval based on ORR and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment. The FDA approved this application 3 months ahead of the FDA goal date.

FDA granted capmatinib orphan drug and breakthrough therapy designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

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