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.

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