BRIEF—Chugai files for additional indication for Alecensa

Japan’s Chugai has filed an application for ALK inhibitor, Alecensa (alectinib) capsule 150mg to the Ministry of Health Labor and Welfare (MHLW) for an additional indication of recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma (ALK-positive ALCL).

Alecensa obtained an orphan drug designation from the MHLW on May 30, said Chugai, which is majority owned by Swiss pharma giant Roche.

“While chemotherapy is known to be effective for ALCL, there is a strong need for development of new therapeutic options since recurrent ALCL often carries a poor prognosis,” said Dr Yasushi Ito, Chugai’s executive vice president, co-head of Project & Lifecycle Management Unit.

This filing is based on the results from the investigator initiated study (the ALC-ALCL study) started in May 2015.

The study has been conducted as a part of “Research Project on Practical Application of Innovative Cancer Therapy” by Japan Agency for Medical Research and Development.

The ALC-ALCL study was a Phase II multicenter clinical study in which the response rate (primary endpoint) was assessed by the central review committee and safety was investigated in 10 patients with recurrent or refractory ALK-positive ALCL.