The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Roche’s alectinib for treatment of people living with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase fusion gene-positive (ALK+).
Alectinib’s approval is supported by data from the Japanese Phase I/II clinical study (AF-001JP), evaluating the drug in people whose tumours were advanced, recurrent or could not be removed completely through surgery.
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The Phase I/II clinical study, which consisted of two phases, was carried out at 13 medical institutions in ALK fusion gene positive recurrent or advanced non-small cell lung cancer patients with a treatment history of one or more chemotherapy regimens.
Phase I of the study evaluated safety, tolerability, pharmacokinetic parameters and recommended dose (24 patients), while Phase II evaluated the efficacy and safety of the recommended dose (46 patients).
Roche chief medical officer and global product development head Sandra Horning said: "Another interesting aspect of alectinib is that based on early studies it may also work in people living with tumours that have spread to the brain, a difficult area to reach with current medicines. Our research will continue in this area."
Roche is expected to launch alectinib in Japan later 2014. In June 2013, the US Food and Drug Administration had granted breakthrough therapy designation for alectinib for patients with ALK+ NSCLC who progressed on crizotinib.
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By GlobalDataAccording to the company, global pivotal studies are currently ongoing, which will further inform on the clinical value of alectinib in this disease setting, as well as in treatment-naive patients.
The results of these studies will be used in future regulatory submissions in the US and Europe.
