Pfizer’s targeted cancer med Xalkori will have to move over in non-small cell lung cancer.
Novartis’ Zykadia now has FDA clearance to compete for previously untreated NSCLC patients who've tested positive for the ALK gene mutation, giving Xalkori its first competition in that patient pool.
Regulators based the approval on phase 3 data showing Zykadia could more than double progression-free survival to 16.6 months compared with standard first-line pemetrexed-platinum chemo.
Previously, the med had been green-lighted only in patients who had already failed on Xalkori.
It’s a lift for Novartis, which is working to boost Zykadia beyond the $91 million it generated in 2016. That haul made up just a tiny fraction of the monster $12.79 billion tally Novartis’ oncology unit posted for the year. Now, the pharma giant will have access to a larger proportion of the ALK-positive population—which makes up 3% to 7% of NSCLC patient pool. And it's not just a bigger number of patients at stake: That first-line group tends to stay on therapy for longer.
Importantly, though, the Novartis go-ahead will put pressure on another med besides Xalkori—Roche's rival Alecensa. The Swiss drugmaker’s contender is also angling for a first-line nod after picking up a breakthrough designation from the FDA last October.
And Novartis isn’t planning to stop there as far as regulatory expansion goes. Earlier this year, Zykadia picked up an FDA breakthrough designation for front-line treatment of ALK-positive lung cancer patients with brain metastases.