The FDA granted
breakthrough therapy designation to capmatinib for first-line treatment of
metastatic MET exon 14 skipping-mutated non-small cell lung cancer.
MET mutations — identified
in approximately 4% of patients with NSCLC — are associated with poor
prognosis. The mutations, typically seen among older patients, can limit
treatment options.
No targeted therapies are approved to treat
MET exon 14 skipping-mutated NSCLC, an aggressive subtype of the disease.
Prior studies have shown
capmatinib (INC280, Novartis) — an investigational, oral MET inhibitor — to be
highly selective and potent in this setting, according to a Novartis-issued
press release. The FDA previously granted breakthrough therapy designation to
the agent for treatment of patients with this type of NSCLC who received prior
platinum-based chemotherapy.
“We look forward to working
with the FDA and global health authorities to bring capmatinib to patients who
currently have no available targeted therapy options,” John Tsai, MD, head
of global drug development and chief medical officer of Novartis, said in the
release.
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