Novartis’s certain cancer combination approved by FDA; fourth actionable genomic biomaker in metastatic NSCLC

Novartis was cleared on Thursday by the US Food and Drug Administration (FDA) for combination of Tafinlar (dabrafenib) with Mekinist (trametinib) for treating metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express the BRAF V600E mutation.

To remind, the FDA granted Tafinlar + Mekinist Breakthrough Therapy designation in July 2015 for the treatment of patients with advanced or metastatic BRAF V600E mutation-positive NSCLC who received previous treatment with chemotherapy.

Novartis’s Oncology CEO, Bruno Strigini said that patients with BRAF V600E mutation-positive metastatic NSCLC have responded less favorably to standard chemotherapy, suggesting that there is a critical need for a targeted therapy. Strigini added that the combination’s approval means further validation to Novartis’s expertise in tumor biology.

This is also the fourth actionable genomic biomarker in metastatic NSCLC – along with EGFR, ALK and ROS-1, said Bruce Johnson, Chief Clinical Research Officer at Dana-Farber Cancer Institute. Johnson said: “This is an important milestone for the lung cancer community as we are continuing to better understand the genomic drivers of cancer and develop effective treatments targeted for these biomarkers.”

Novartis said that an in-depth analysis of data from the treatment-naïve cohort will be presented at an upcoming medical meeting.

The treatment combination was approved with Thermo Fisher Scientific’s Oncomine(TM) Dx Target Test to identify a BRAF V600E mutation in eligible patients. This qualitative in vitro diagnostic test uses targeted high throughput, parallel-sequencing technology to detect sequence variations in select genes, including BRAF V600E, in DNA and RNA isolated from formalin-fixed, paraffin-embedded tumor (FFPE) tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM(TM) Dx System.

Tafinlar + Mekinist was approved by the European Commission (EC) in March 2017 for the treatment of patients with BRAF V600 advanced mutation-positive NSCLC.