Alectinib’s approval was based on data from a Japanese Phase I/II clinical trial (AF-001JP) for people whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable).
The trial was carried out in 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.
It included two phases: Phase I that assessed safety, tolerability, pharmacokinetic parameters and recommended dose (24 patients), and a Phase II part that evaluated the efficacy and safety of the recommended dose (46 patients).
The company intends to make the drug available in Japan later in 2014.
In June 2013, the US Food and Drug Administration (FDA) had granted breakthrough therapy designation (BTD) to alectinib for patients with ALK+ NSCLC who progressed on crizotinib.
Roche chief medical officer and head of Global Product Development Sandra Horning said 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.
"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," Horning said.
Currently, alectinib is evaluated in global pivotal studies, which will further inform on the clinical value of the drug in this disease setting as well as in treatment-naïve patients.
The company said that the results of these studies will be used in future regulatory submissions in the US and in Europe.
Image: Roche’s lung cancer drug alectinib will be available in Japan later in 2014.Photo: courtesy of foto76/ freedigitalphotos.net