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Roche's Alectinib Approved in Japan

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Roche (RHHBY) received positive news  when the Japanese Ministry of Health, Labour and Welfare (:MHLW) approved alectinib for the treatment of patients suffering from non-small cell lung cancer (:NSCLC) that is anaplastic lymphoma kinase fusion gene-positive (ALK+).

The approval was based on encouraging results from a phase I/II clinical study (AF-001JP) conducted in Japan among patients whose tumors were advanced, recurrent or could not be removed completely through surgery.

The trial consisted of two phases – in phase I, the safety, tolerability, pharmacokinetic parameters and recommended dose (24 patients) of alectinib was evaluated and phase II evaluated the efficacy and safety of the recommended dose. The data from the study showed that 90% of the patients responded to the treatment with alectinib.

Alectinib will be available in Japan later this year. We note that alectinib was granted Breakthrough Therapy Designation by the FDA in Jun 2013 for patients suffering from ALK+ NSCLC who progressed on Xalkori.

Meanwhile, Roche is conducting clinical studies on a global basis to evaluate alectinib for this indication as well as in treatment-naïve patients. Roche expects to use the results of these studies for regulatory submissions in the U.S. and Europe.

We note that Roche’s Avastin and Tarceva are already approved for the treatment of various types of lung cancer. The approval of alectinib in Japan and a potential approval in the U.S. and EU will further boost Roche’s oncology franchise.

Roche specializes in oncology drugs. In particular, the company is a leader in breast cancer franchise and continues to innovate further to strengthen its already dominant position.

Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader healthcare sector include Abbott Labs (ABT), Allergan (AGN) and Shire (SHPG). All three stocks carry a Zacks Rank #2 (Buy).

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