Chugai gains approval for additional indications on three drugs

In a bonanza day for the Japanese drugmaker, Chugai Pharmaceutical (TYO: 4529) today announced that expanded indications have been approved by the domestic regulator for three of its already-marketed medicines. Market reaction was slim, with Chugai’s shares gaining just 1.4% to 12,255 yen by close of trading.

Chugai, which is majority-owned by Swiss pharma giant Roche (ROG: SIX), has obtained approval for its anti-cancer agent/ALK inhibitor, Alecensa capsule (alectinib hydrochloride) 150mg from the Ministry of Health, Labor and Welfare (MHLW) for an additional indication of recurrent or refractory ALK fusion gene-positive anaplastic large-cell lymphoma.

This approval is based on the results from the investigator-initiated study (the ALC-ALCL study) started in May 2015. The study was conducted as a part of the “Research Project on Practical Application of Innovative Cancer Therapy” by Japan Agency for Medical Research and Development. In the ALC-ALCL study, the response rate (primary endpoint, assessed by the central review committee) and safety were evaluated in 10 patients with relapsed or refractory ALK-positive ALCL who are six years or older (6-70 years).