(Reuters) - Novartis AG on Wednesday received the U.S. Food and Drug Administration’s approval for its drug to treat patients with a tough-to-treat form of lung cancer, the drugmaker said.
The drug, Tabrecta, has been approved to treat patients with a MET exon14 skipping-mutated non-small cell lung cancer that has spread to other parts of the body, the agency said. (bit.ly/2xKvaqc)
Tabrecta is approved for both untreated and previously treated patients, regardless of prior treatment type, and is expected to be available to patients in the coming days, Novartis said.
This is the first approved treatment to specifically target METex14 mutated metastatic non-small cell lung cancer (NSCLC), a type of lung cancer with a particularly poor prognosis.
With the approval, Novartis beats Pfizer Inc in the race to develop a treatment for this specific form of lung cancer. Pfizer drug Xalkori in 2018 also won the FDA’s fast-track development for METex14 metastatic NSCLC.
Drugmakers like Novartis are increasingly using biomarker-driven drugs to treat patients with rare tumors - only about 3%-4% of lung cancer patients have the MET exon14 skipping mutation - that have proven very difficult for oncologists to fight with their existing arsenal of medicines.
Only about 4,000-5,000 patients are diagnosed with METex14 metastatic NSCLC each year in the United States, according to Novartis. In contrast, NSCLC accounts for about 228,000 new diagnosis in the country each year, the company said.
Tabrecta, which Novartis licensed from Incyte Corp in 2009, got a priority review from the FDA in February.
With the approval, Incyte is eligible to receive over $500 million in future milestones as well as royalties of between 12% and 14% on global sales by Novartis. (bwnews.pr/3fqlzpp)
The FDA said on Wednesday it also approved Foundation Medicine Inc’s FoundationOne CDx assay as a companion test for Tabrecta.
Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta and Shailesh Kuber