) 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
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
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
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
). All three stocks carry a Zacks Rank #2 (Buy).
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