Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs

European Commission conditionally approves Roche’s cancer drug Alecensa

PBR Staff Writer Published 22 February 2017

Roche's oral ALK inhibitor, Alecensa, has been conditionally approved in the European Union as a monotherapy for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) in adults who were earlier treated with crizotinib.

Alecensa, which is an oral medicine produced at Chugai Kamakura, is being developed for people with NSCLC whose tumours are identified as ALK-positive.

The European Commission has granted approval based on data from the pivotal phase II NP28673 and NP28761 studies, which demonstrated that Alecensa contracted tumours in around 52.2% of people with advanced ALK-positive NSCLC.

NP28673 is a phase I/II global, single arm, open-label and multicentre study, which is assessing the safety and efficacy of Alecensa in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib.

As per provisions of the conditional approval, Roche will offer additional data on first-line Alecensa in ALK inhibitor naïve ALK-positive NSCLC patients from an ongoing phase III study ALEX, compared to Alecensa to crizotinib.

The company plans to present the data from the ALEX study in the first half of this year.

Roche received approval for Alecensa for ALK-positive NSCLC in eight countries in the crizotinib failure setting, while in Japan for people whose tumours were advanced, recurrent or could not be removed completely through surgery.

Alecensa is being studied as a first-line treatment option in phase III J-ALEX study comparing Alecensa to crizotinib in Japanese patients, in addition to ALEX.

Roche global product development head and chief medical officer Sandra Horning said: “Every year, an estimated 75,000 people are diagnosed with ALK-positive NSCLC worldwide.

“Development of resistance to the current standard of care underlines the need for alternative treatments. Today’s approval provides the promise of a new treatment option for people in Europe with this devastating disease.”


Image: Site Roche Basel. Photo: courtesy of F. Hoffmann-La Roche Ltd.