Combos, FDA

FDA adds fresh ‘breakthrough’ for Novartis’ cancer combo Tafinlar and Mekinist

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.

Samit Hirawat, Novartis Oncology

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.”



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