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Novartis FDA Approval

Posted at 5:13 PM, Jun 30, 2020
and last updated 2020-06-30 17:13:10-04

Lung cancer is the leading cause of cancer deaths in the United States. It claims more lives each year than colon, prostate, ovarian and breast cancers combined.

Non-small cell lung cancer (NSCLC), accounts for approximately 85% of new lung cancer diagnoses each year worldwide, including 228,000 in the United States. A complex disease, NSCLC could have many different types of mutations that may promote the cancer’s growth. In fact, nearly 70% of NSCLC patients have an identifiable genomic mutation driving their cancer, such as the aggressive MET exon 14 skipping (METex14), observed in approximately 3% to 4% of newly diagnosed metastatic NSCLC cases (about 4,000 – 5,000 patients in the US annually). These patients may face poor prognosis due to the presence of METex14. So it is important for patients to speak with their doctor at the time of diagnosis and when their disease progresses to determine their mutational status.

Until recently, patients with mNSCLC with METex14 have not had a treatment option approved to specifically target the driver of their NSCLC. The U.S. Food and Drug Administration has now approved Tabrecta™ (capmatinib) tablets, for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14, as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

This approval fills a long-recognized and urgent need among patients with METex14. Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type, and is now available to patients.

On June 24, 2020, Dr. Edward B. Garon will be available for interviews. He will discuss the recent FDA approval, why this new treatment is so meaningful and the latest statistics on lung cancer.