Updated on 15 December 2015
Japanese pharma major Chugai Pharmaceutical Co. Ltd. announced that Genentech Inc, a member of the Roche Group, obtained approval from the US Food and Drug Administration (FDA) for the anti-cancer agent, alectinib hydrochloride, Alecensa, for the indication of anaplastic lymphoma kinase (ALK) positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or those intolerant to crizotinib.
"Alecensa was created by Chugai and in July 2014, Japan became the first country in the World to receive approval. We believe that the FDA's priority review of Alecensa will bring fresh hope for patients in the US living with this disease," said Chugai's Director and Executive Vice President, Dr. Yutaka Tanaka. "We are extremely pleased that Alecensa can contribute to the treatment of patients with ALK positive NSCLC."
Alecensa was granted Breakthrough Therapy Designation by FDA in June 2013 for patients with ALK positive NSCLC who have progressed on crizotinib. And FDA also granted priority review for Alecensa in September 2015.
The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit. The indication for Alecensa is approved under accelerated approval based on tumor response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
ALEX is a global, randomized phase III study comparing Alecensa to crizotinib as an initial treatment for people with advanced ALK-positive NSCLC. This study is part of the company's commitment to convert the current accelerated approval in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval as an initial treatment.
Alecensa is a highly selective ALK inhibitor created by Chugai. In Europe, Roche filed the NDA to the European Medicines Agency for the approval of ALK fusion gene positive unresectable, recurrent/advanced NSCLC' in September 2015. Chugai has out-licensed the rights of Alecensa to Roche in overseas countries including Europe and the US. In Japan, Alecensa capsule 20mg, 40mg and 150mg is available to patients with ALK fusion gene positive unresectable, recurrent/advanced NSCLC and is marketed by Chugai.