Novartis lung cancer combo receives FDA approval
pharmafile | June 23, 2017 | News story | Medical Communications, Sales and Marketing |Â Â NSCLC, NovartisÂ
Novartis has revealed that its drug Tafinlar (dabrafenib) has received approval from the FDA for use in combination with Mekinist (trametinib) in the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours express the BRAF V600E mutation.
The decision was based on data generated from a Phase 3 trial examining patients with stage IV BRAF V600E mutant NSCLC. Of the total participants, 36 had not received treatment for their condition, while 57 had been previously treated with chemotherapy. The untreated group recorded an overall response rate (ORR) of 61%, while the second group recorded a rate of 63%. Additionally, median duration of response was 12.6 months in the previously treated group, but was not estimable in the untreated group. The combination was approved for the same indication in Europe in March 2017.
“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,” said Bruno Strigini, CEO at Novartis Oncology. “Today’s approval of the Tafinlar and Mekinist combination validates our expertise in tumour biology, which enabled us to develop the first targeted treatment for people with this rare mutation.”
Bruce Johnson, Professor of Medicine and Chief Clinical Research Officer at the Dana-Farber Cancer Institute and Harvard Medical School at Dana-Farber Cancer Institute, added: “The approval of Tafinlar and Mekinist makes BRAF V600E the fourth actionable genomic biomarker in metastatic NSCLC – along with EGFR, ALK and ROS-1. 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.”
Matt Fellows
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