Just four months after adding an FDA OK to sell its combo of Tafinlar and Mekinist for non-small cell lung cancer with a BRAF V600E mutation, Novartis says that US regulators have handed them another breakthrough therapy designation on stage III melanoma.
The BRAF/MEK combination — bagged in their big asset swap with GlaxoSmithKline — should now get VIP treatment for stage III melanoma cases involving this particular mutation after investigators posted a 53% reduction in the risk of death or recurrence in Phase III compared to placebo last month.
The red-carpet treatment Novartis has won at the FDA underscores its increased focus on oncology, particularly after the recent approval of its pioneering CAR-T drug Kymriah.
The primary endpoint in the study was relapse-free survival. Investigators reviewed the data at ESMO in Madrid last month, with a 58% relapse-free survival rate in the combo arm compared to 39% in the placebo group.
At the time study co-author Axel Hauschild said:
There is no standard of care for the adjuvant treatment of stage III melanoma. Interferon is approved for this situation but improves relative relapse-free survival by just 20% compared to placebo.
“There is a need for more effective treatment options for stage III melanoma patients at a high risk of recurrence following surgical resection,” said Samit Hirawat, who runs R&D in Novartis Oncology. “We thank the FDA for recognizing the scientific advancement Tafinlar and Mekinist may provide in this adjuvant setting.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,700+ biopharma pros who read Endpoints News by email every day.Free Subscription