Chugai Pharmaceutical, a subsidiary drug manufacturer operating in Japan controlled by Hoffmann–La Roche, has launched the ALK inhibitor “Alecensa capsule 20mg and 40mg” (alectinib hydrochloride) for the indication of “ALK fusion gene positive unresectable, recurrent/advanced non-small cell lung cancer.”  Alecensa received a manufacturing and marketing approval on July 4, 2014 and was listed on the National Health Insurance (NHI) reimbursement price list on September 2, 2014.

Alecensa is a highly selective ALK inhibitor created at Chugai Kamakura Research Laboratories. Alecensa exemplifies the Personalised Healthcare (PHC) Strategy promoted by Chugai and F. Hoffmann-La Roche Ltd. [Head Office: Basel, Switzerland. chief executive officer, Severin Schwan] (hereafter, “Roche”). PHC is intended to determine the patients who are likely to respond to therapy by using diagnostic tools and/or biomarkers. PHC has the potential to deliver significant benefits in terms of therapeutic effects and health economics.

It has been reported that in 2 to 5 per cent of patients with non-small cell lung cancer, a chromosomal rearrangement results in fusion of the ALK gene with another gene. ALK kinase signaling is constantly active in cells with such fusion genes, resulting in uncontrolled growth and transforming the cells into tumour cells. Alecensa exerts its anti-tumour effect by selectively inhibiting ALK kinase activity, resulting in inhibition of tumour cell proliferation and induction of cell death.

The rights to Alecensa in overseas countries including Europe and the US were out-licensed to Roche in 2012, and clinical trials of Alecensa (Roche Development Code: RG7853) are currently ongoing in the US, Europe and other countries.

As the top pharmaceutical company in the field of oncology in Japan, Chugai will promote appropriate use so that Alecensa can contribute optimally to the treatment of patients with “ALK fusion gene positive unresectable, recurrent/advanced non-small cell lung cancer” by providing a new therapeutic option.

The conditions for approval were given as: “Alecensa will be handled by doctors, medical institutions and pharmacists, who have sufficient experience in diagnosis and chemotherapy in lung cancer and who can appropriately control risks associated with Alecensa; a drug use surveillance of all patients who receive Alecensa should be conducted until the data of a certain number of patients are accumulated”.

For the first 1,000 patients who receive Alecensa treatment, data will be collected, analyzed and reported to the health authority. After collecting data for 1,000 cases, a review and decision will be made to determine whether a new surveillance or further safety measures should be considered. Results of this surveillance shall be reported to the public in future scientific meetings, as well as to the regulatory authorities.