Japan Is First To Approve Roche Lung Cancer Drug
By Lori Clapper
Roche announced last week that the Japanese Ministry of Health, Labor and Welfare (MHLW) approved its lung cancer drug alectinib. Studies showed that over 90 percent of participants in a Japanese clinical study responded to treatment with alectinib.
The drug will be manufactured for the treatment of anaplastic lymphoma kinase fusion gene-positive (ALK+) non-small cell lung cancer (NSCLC). The approval stemmed from positive results from a Japanese Phase 1/2 clinical study (AF-001JP) for people whose tumors were advanced, recurrent or could not be removed completely through surgery, according to Roche’s announcement.
The clinical trial was conducted in 13 medical institutions in ALK fusion gene positive recurrent or advanced nonsmall cell lung cancer patients with a treatment history of one or more chemotherapy regimens, according to Roche. Phase 1 evaluated safety, tolerability, pharmacokinetic parameters, and recommended dose, and Phase 2 evaluated the efficacy and safety of the recommended dose.
Roche expects Alectinib will be available in Japan in late 2014. In June 2013, the U.S. Food and Drug Administration (FDA) granted Alectinib Breakthrough Therapy Designation (BTD). This designation is designed to speed up a drug’s development and review process, as preliminary trial data shows that the treatment could be more effective than those currently available for a serious illness, according to the FDA.
“The approval of alectinib, a treatment specifically targeted to ALK+ lung cancer, in Japan is great news for people living with this difficult to treat disease,” Sandra Horning MD, Roche’s CMO and Head of Global Product Development, said.
Global pivotal studies, which may further the clinical value of alectinib in this disease setting as well as in treatment-naïve patients, are currently happening. The results of these studies will be used in future regulatory submissions in the U.S. and in Europe.
Horning added that early research studies show that Alectinib may also work in people living with tumors that have spread to the brain, which, to date, has been tough to treat effectively, but Roche plans to continue research in that area.