Tabrecta demonstrated 68% overall response rate in treatment-naive patients and 41% in previously treated METex14 patients
FDA approves Novartis’ metastatic NSCLC treatment Tabrecta. (Credit: Novartis AG.)
Novartis has secured the US Food and Drug Administration (FDA) approval for Tabrecta (capmatinib), an oral MET to treat a type of metastatic non-small cell lung cancer (NSCLC) in adult patients.
Tabrecta has been indicated for treating adult patients with metastatic NSCLC, with a mutation in their tumour that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. The indication has been approved based on overall response rate and duration of response.
GEOMETRY study lead investigator Juergen Wolf said: “Non-small cell lung cancer is a complex disease, with many different possible mutations that may encourage the cancer’s growth.
“MET exon 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 harbouring this type of mutation.”
FDA approval for Tabrecta is based on results from the Phase 2 GEOMETRY mono-1 study
Tabrecta is a kinase inhibitor that targets MET, for which Novartis holds exclusive development and commercialisation rights and certain back-up compounds in all indications, around the world.
Novartis said that the FDA approval will address an urgent need of METex14 patients who are devoid of an approved treatment option to specifically target the driver of lung cancer.
In addition, Tabrecta has also been granted FDA Breakthrough Therapy Designation, and FoundationOneCDx has been approved as the companion diagnostic for the drug.
The regulatory approval for Tabrecta is supported by results from the Phase 2 GEOMETRY mono-1 study, a multi-centre, non-randomised, open-label, multi-cohort clinical trial.
The study confirmed that the drug has demonstrated a 68% overall response rate in treatment-naive patients and 41% in previously treated METex14 patients, based on the blinded independent review committee (BIRC) assessment.
Novartis Oncology president Susanne Schaffert said: “Today, and especially during these difficult times, we are incredibly proud that Tabrecta is the first treatment approved by the FDA specifically to treat patients diagnosed with this aggressive NSCLC associated with METex14.
“In our quest to reimagine medicine, we have worked tirelessly over the past decades to advance the understanding and treatment of NSCLC, striving to make a difference in patients’ lives, one mutation at a time.”