Novartis announces FDA approval of MET inhibitor Tabrecta for metastatic non-small cell lung cancer with METex14 - Seite 3

Novartis is committed to providing patients with access to medicines, as well as resources and support to address a range of needs. The Novartis Oncology Patient Support Program is available to help guide eligible patients through the various aspects of getting started on treatment, from providing educational information to helping them understand their insurance coverage and identify potential financial assistance options. Patients or providers can call 800-282-7630 or visit Patient.NovartisOncology.com or HCP.Novartis.com/Access to learn more about eligibility and to enroll.

Full prescribing information for Tabrecta can be found at https://www.novartis.us/sites/www.novartis.us/files/tabrecta.pdf.

About Tabrecta (capmatinib)
Tabrecta (capmatinib) is a kinase inhibitor that targets MET. Tabrecta is licensed to Novartis by Incyte Corporation in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

About GEOMETRY mono-1
GEOMETRY mono-1 is a Phase II a multi-center, non-randomized, open-label, multi-cohort study in adult patients with EGFR wild-type, metastatic NSCLC as measured by ORR.

The trial evaluated 97 adult patients with metastatic NSCLC harboring mutations that lead to METex14 (centrally confirmed) who were assigned to Cohorts 4 (n=69, previously treated patients) or 5b (n=28, treatment-naive), and received capmatinib tablets 400 mg orally twice daily.

The major efficacy outcome is ORR based on BIRC assessment per RECIST v1.1.  An additional efficacy outcome is duration of response by BIRC.

Novartis Commitment to Lung Cancer
Worldwide, lung cancer causes more deaths than colon, breast and prostate cancer combined, and more than 2 million new cases of lung cancer are diagnosed each year⁴. Despite treatment advances, many patients with NSCLC still have a poor prognosis and limited treatment options³. This includes the nearly 70% of NSCLC patients who have a genomic mutation⁶. To determine the most appropriate treatment, medical organizations recommend comprehensive genomic testing for patients with lung cancer as part of their upfront diagnosis⁷.