Novartis' Zykadia gets a front-line boost in lung cancer race against Roche

Novartis' Zykadia and Roche's Alecensa are both gunning for front-line nods in ALK+ NSCLC.

Novartis isn’t letting its crosstown rival get all the regulatory attention when it comes to ALK+ metastatic non-small cell lung cancer.

On Thursday, it moved toward evening the score with nemesis Roche, winning an FDA priority review for cancer-fighter Zykadia as a first-line treatment for patients with the disease. It also picked up the agency’s breakthrough designation for first-line treatment of ALK+ NSCLC patients with brain metastases.

It’s a step in the right direction for Zykadia, which is currently approved for patients who have already failed on Pfizer’s Xalkori. Last September, the Novartis med showed it could top standard chemo at improving progression-free survival in the front-line setting, hitting secondary endpoints in objective response rate and duration of response, too.


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Still, though, it’s trailing behind Roche competitor Alecensa, both in the regulatory race and in the sales department. Alecensa picked up a first-line breakthrough tag from the FDA last October, and through the first half of last year, it generated $74 million compared with Zykadia’s $48 million.

That’s partly because Zykadia hasn’t seen much expansion lately. In 2016’s Q3, it brought in $21 million in sales—the same figure it reached in that period the year prior.