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Japan : Ant-cancer agent Alecensa capsules introduced by Chugai Pharma
Publish Date : 09-Sep-2014
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” is introduced by Chugai Pharmaceutical, a subsidiary drug manufacturer operating in Japan controlled by Hoffmann–La Roche. Alecensa obtainws a manufacturing and marketing authorization on July 4, 2014 and was registered on the National Health Insurance (NHI) reimbursement price list on September 2, 2014.
Alecensa is a extremely choosy ALK inhibitor created at Chugai Kamakura Research Laboratories. Alecensa demonstrates 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 planned to decide the patients who are expected to react 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 stated that in 2 to 5 % 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 continuously 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 out of the country countries counting Europe and the US were out-licensed to Roche in 2012, and clinical trials of Alecensa (Roche Development Code: RG7853) are at present ongoing in the US, Europe and other countries. Chugai as the top pharmaceutical company in the field of oncology in Japan will encourage 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”.
