Novartis preps Zykadia for a frontline NSCLC pitch, but faces a tough rival in Roche; J&J, GSK hustle RA drug sirukumab to the FDA

Novartis plans to hustle to regulators with new late-stage data on their cancer drug Zykadia (certinib), looking for an approval to move up to first-line treatment of ALK-positive non-small cell lung cancer. Investigators say the drug outperformed standard chemo in previously untreated patients for progression free survival. There were also “clinically meaningful” improvements in the overall response rate and duration of response, though that will need to be clarified when the data is released. Novartis is looking to considerably enhance its market for this drug, given an accelerated approval two years ago as a  second-line therapy. If OK’d, though, it will need to face down Pfizer’s Xalkori (crizotinib) as well as Roche’s Alecensa (alectinib). That won’t be smooth sailing. Analysts give Alecensa the edge in the competition, with some very appealing data compared to Xalkori that Novartis will find tough to beat.

Hot on the heels of their European application, J&J has submitted its rheumatoid arthritis drug sirukumab, partnered with GSK, for approval in the US. Sirukumab is an IL-6 drug, and there are a variety in development now that will challenge J&J and GSK in the coming scramble for market share. Ablynx recently posted Phase IIb ACR20 rates ranging from 62% to 81% in a variety of patient groups taking vobarilizumab.

Paul Campanelli

Paul Campanelli

Among the comings and goings in the executive suite this week, Endo CEO Rajiv De Silva has stepped down from his post and will be replaced by Paul V. Campanelli, the current chief of its generic and OTC divisions. Campanelli is the former CEO of Par, which was bought out by Endo in 2015.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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