Roche and Chugai’s oral anaplastic lymphoma kinase (ALK) inhibitor Alecensa® (alectinib) was granted conditional approval by the European Commission as monotherapy for treating ALK-positive advanced non-small-cell lung cancer (NSCLC) in adult patients who have previously been treated with crizotinib.
Alecensa was originally discovered by Roche’s majority-owned Japanese drugmaker Chugai. Roche has developed the drug in markets including the U.S. and Europe. Conditional approval of Alecensa in the EU is based on data from the pivotal Phase II NP28673 and NP28761 trials. The studies demonstrated that Alecensa therapy shrank tumors in up to 52.2% of patients in the target population and increased progression-free survival by up to 8.9 months.
“We believe that the approval of Alecensa by the EC will bring great hope for patients in the EU living with this disease,” said Dr. Yasushi Ito, Chugai’s svp, Head of Project & Lifecycle Management Unit. “We are extremely pleased that Alecensa can contribute to the treatment of patients with ALK-positive NSCLC in each country.”
Alecensa is already approved in the U.S., Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, and India for the treatment of advanced (metastatic) ALK-positive NSCLC in patients with disease that has progressed after, or who could not tolerate treatment with, crizotinib. Approval in Japan covers the treatment of ALK-positive NSCLC patients. Under terms of the conditional approval in the EU, Roche will have to provide additional data on first-line Alecensa therapy in ALK inhibitor naïve ALK-positive NSCLC patients from the ongoing Phase III study ALEX. Data from the ALEX trial, which is comparing Alecensa to crizotinib, is expected during the first half of 2017.