Swiss pharma giant Roche (ROG: SIX) has scored an important win in lung cancer that will see its product Alecensa (alectinib) put into direct competition with a drug from Pfizer (NYSE: PFE) in the USA.
The US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Alecensa as a first-line treatment for anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
This approval is based on results from a Phase III study which showed that Alecensa reduced the risk of disease worsening or death by half compared to crizotinib, a drug marketed by Pfizer under the name Xalkori. Alecensa was previously approved for patients who have been treated with Xalkori whose disease had nonetheless progressed, but this now allows it to be given out before treatment with the Pfizer drug.
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