Novartis grabs Zykadia approval in Europe, setting the stage for showdown
May 8, 2015 | By Emily Wasserman

Novartis' ($NVS) Zykadia picked up some steam in its head-to-head rivalry with Pfizer's ($PFE) Xalkori, snagging EU approval and setting the stage for a showdown as the companies compete for top dog.

The Basel-based drugmaker got a greenlight from European regulators for Zykadia in individuals with ALK-positive non-small cell lung cancer whose disease has worsened, even after treatment with Pfizer's Xalkori. The regulatory blessing comes a little more than a year after Novartis scored early FDA approval for the drug, reaping the benefits of FDA Oncology Chief Richard Padzur's commitment to usher through breakthrough cancer therapies that help difficult-to-treat patients.

"The approval of Zykadia in the European Union is significant for ALK+NSCLC patients who have exhausted other treatment options for their disease," Bruno Strigini, president of Novartis Oncology, said in a statement. "This approval is yet another example of our commitment to precision oncology and our continued focus on developing treatment approaches that target specific genetic and molecular characteristics of cancer."

EU regulators based their approval on two global, multicenter studies which showed improvement in previously-treated patients after taking Zykadia. The first study looked at 246 ALK-NSCLC patients who were treated with 750 mg of the drug, and found that more than half--or 56%--of individuals responded to the therapy. Novartis is staying mum on the results of the second study, which evaluated 140 patients who were treated with chemotherapy and Xalkori, but plans to release the data at an upcoming medical congress, the company said in a statement.

European approval for Zykadia gives Novartis a boost at it struggles to catch up to archrival Pfizer and its PD-L1 powerhouse Xalkori. Zykadia brought in $16 million during Q1 2015, and analysts predict sales could eventually peak at around $300 million. But Xalkori brought in $111 million in sales during the same quarter and is expected to reach $800 million in peak revenues, leaving Novartis with some serious ground to cover. And Pfizer and Merck KGaA are not wasting any time trying to lengthen their lead, teaming up last month to promote Xalkori in the U.S. and several other countries.

But Novartis is still forging ahead with Zykadia, carrying out clinical trials of the drug as a first-line treatment for patients with ALK + NSCLC who do not respond to therapy. The approval comes as the company hopes to strengthen its position in oncology after its three-way asset swap with GlaxoSmithKline ($GSK), in which it picked up Glaxo's cancer drug portfolio in exchange for Novartis' vaccines business.