NOVARTIS LUNG CANCER DRUG TABRECTA (CAPMATINIB) EARNS FDA APPROVAL
by John G. Baresky on 05/09/20
Tabrecta is a highly specialized
oncology therapy
The oncology portfolio of Novartis (NYSE: NVS) continues to expand with the FDA approval of Tabrecta. The FDA made its decision through its accelerated approval process. Tabrecta is indicated for metastatic non-small cell lung cancer (NSCLC) with METex14. Only 3 to 4% of lung cancer patients have this diagnosis but up to now there were not any targeted therapy or other treatment options available for it.
Tabrecta is an oral MET inhibitor for adult patients with metastatic NSCLC whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test.
An important attribute of Trabecta's is that it is approved for first-line and previously treated patients --regardless of prior treatment type. This greatly reduces any issues with managed care organization (MCO), prescription benefit management (PBM) and specialty pharmacy formulary rules and prior authorization requirements. Novartis will benefit from more direct and streamlined market access for the product as will oncologists and their patients.
It is available by prescription only and comes in 150 mg and 200 mg strength tablets. Oncologists will be embracing this unique and valuable treatment option to better care for this group of patients.
Incyte is the company that originally developed Tabrecta and Novartis licensed the rights to it
Novartis has exclusive global rights to Tabrecta and based on its commercialization success will be paying Incyte (NASDAQ: INCY) a milestone fee of $70 million. Moving forward, Incyte is in line to be paid an additional 12% to 14 % of net sale royalty fees of Tabrecta by Novartis.
Incyte was founded in 1991 in Palo Alto, California and is officially headquartered in Alopacas, Delaware. The company generates about $2.16 billion in annual sales. Novartis is based in Basel, Switzerland; established in 1996 it produces about $48.7 in yearly sales.
