FDA

The FDA opens an inside track to let Novartis race ahead on Zykadia as Roche rivalry heats up

Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis

Novartis just leaped forward with its cancer drug Zykadia (ceritinib), gaining a priority review from the FDA as a frontline treatment for ALK-positive non-small cell lung cancer as well as breakthrough status for lung cancer patients with brain metastases. The advances are keeping the pharma giant close to their fellow Basel residents at Roche in their head-to-head rivalry with Alecensa, which analysts have blessed as the odds-on winner.

Last fall Novartis noted that Zykadia had aced a Phase III study for lung cancer, handily beating out chemotherapy in holding back ALK-positive lung cancer progression among patients previously treated with Pfizer’s Xalkori. Roche’s Alecensa has a breakthrough drug designation — a likely indicator of a quick OK in this case — for use as a frontline drug in ALK-positive lung cancer.

Alecensa has jumped to an early, though small, sales lead as the two Big Pharma companies duke it out over frontline status. And Roche landed its second breakthrough designation from the FDA last October after their drug beat out Xalkori among Japanese patients with an ALK-positive form of the disease.

The FDA is likely to act quickly on both of these drugs, possibly not even waiting out the full six-month review for Zykadia now that Novartis will get a priority review. In Novartis’ Phase III Zykadia patients had a median progression-free survival rate of 16.6 months compared to 8.1 months for chemo.

There are about 1.8 million lung cancer diagnoses each year and roughly 2% to 7% of cases are ALK-positive. Alecensa is manufactured by Roche’s big Genentech subsidiary.

“We are committed to advancing our understanding of mutation-driven lung cancer, where there continues to be significant unmet need,” said Vas Narasimhan, Global Head Drug Development and Chief Medical Officer, Novartis. “Today`s Priority Review of Zykadia for newly diagnosed patients with ALK+ metastatic NSCLC, including Breakthrough Therapy designation for those with brain metastases, brings us closer to delivering the right treatment to the right patient at the right time.”



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