As of Friday, Roche ($RHHBY) has a new FDA approval in hand for lung cancer treatment Alecensa--and with it, it's about to go head to head with its crosstown rival.
Alecensa won agency approval for ALK-positive non-small cell lung cancer patients who've relapsed after taking Pfizer's ($PFE) Xalkori--or those who couldn't tolerate Xalkori to begin with. And that's the same indication Novartis' ($NVS) Zykadia boasts.
Roche's fellow Basel, Switzerland-based drugmaker has a significant head start, of course. After winning a quick FDA approval in April 2014, Zykadia grabbed its European green light in May this year. The drug pulled in $21 million last quarter, helping boost Novartis' cancer portfolio--recently bolstered by the addition of GlaxoSmithKline's ($GSK) oncology meds--to $3.5 billion.
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| Roche's new HQ building in Basel, Switzerland |
But Roche has its advantages when it comes to targeted markets. It's got plenty of experience hawking drugs that require genetic testing--see: blockbuster Herceptin, for patients with HER2-positive breast cancer, and fast-growing newcomers Perjeta and Kadcyla--which means experience getting doctors into the habit of ordering the tests. And it also makes diagnostics in-house; this June, it won FDA approval for an ALK companion diagnostic, developed to identify patients eligible for first-line Xalkori treatment.
Roche is hoping that same test will help it tag patients for first-line treatment with Alecensa sooner rather than later. It's studying its new med as an initial therapy in a Phase III study that pits it against the Pfizer drug.
Meanwhile, though, Pfizer is working to broaden its patient pool in advance of any first-line competition. Last week, U.S. regulators granted the pharma giant a priority review for Xalkori in patients with ROS1-positive lung cancer, which affects about 1% of NSCLC sufferers.
- read Roche's release
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