Roche wins FDA approval for a new lung cancer drug

Roche ($RHHBY) picked up an accelerated FDA approval for its latest lung cancer therapy, planning to market the treatment for severely ill patients while building the clinical case for wider use.

The drug, alectinib, blocks the enzyme ALK to shrink tumors for the roughly 5% of non-small cell lung cancer patients with gene mutations that express ALK. The FDA's approval clears the drug for use in patients whose lung cancer has spread despite prior treatment with Pfizer's ($PFE) Xalkori, another ALK inhibitor,  and Roche plans to sell alectinib under the brand name Alecensa.

The FDA shuttled alectinib into its accelerated approval program last year, signing off on the drug based on a pair of mid-stage studies in which Roche's drug shrunk tumors in 38% and 44% of patients. The company is now at work on a Phase III trial comparing Alecensa with Xalkori, looking to extend patient survival and broaden the drug's approval to include first-line treatment for ALK-positive lung cancer.

Roche, hoping to differentiate its candidate from Xalkori and Novartis' ($NVS) similar Zykadia, has pointed to Alecensa's effects on lung cancer that has spread to the brain, which is common in ALK-mutated malignancies. In its two Phase II trials, the drug charted a 61% response rate in patients with brain or CNS metastases.

The FDA's cancer division, led by Richard Pazdur, has made a habit of quickly approving new oncology treatments based on Phase II data, giving each drug a second- or third-line indication to provide more options for seriously ill patients while holding out for pivotal trials before widening any labels. Alecensa received the FDA's breakthrough, priority review and orphan drug designations on its way to approval.

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