Please login to the form below

Not currently logged in

Roche’s lung cancer drug Alecensa wins EU approval

Monotherapy conditionally approved as second-line NSCLC treatment

The European Commission has approved Roche's Alecensa (alectinib) as a second-line therapy for patients with ALK-positive non-small cell lung cancer (NSCLC).

The regulatory authority's decision was based on the results of two phase II studies, which showed that Alecensa shrank tumours in up to 52.2% of patients whose disease had progressed after treatment with Pfizer's Xalkori (crizotinib), the current standard.

The monotherapy was also able to extend progression-free survival by up to 8.9 months in these patients, while 64% of patients whose disease had spread to parts of the central nervous system (CNS) saw measurable shrinkage of CNS tumours.

Alecensa has been available in the US since December 2015, when it won accelerated FDA approval as a second-line NSCLC therapy after being awarded breakthrough designation two months prior.

However, its licensing in the EU is conditional on the provision of further trial data on Alecensa's clinical efficacy as a first-line treatment for ALK-positive NSCLC patients. Results from Roche's ongoing phase III ALEX study comparing Alecensa and Xalkori are expected by June this year.

Dr Sandra Horning, chief medical officer and head of global product development, 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.”

Article by
Rebecca Clifford

21st February 2017

From: Regulatory



Featured jobs

Subscribe to our email news alerts


Add my company
Wilmington Healthcare

A heritage to envy Wilmington Healthcare brings together the data intelligence specialisms of Binley’s, NHiS, Wellards and HSJ to create...

Latest intelligence

figure 1
The valuable brand
Creating value beyond the pill is both possible and increasingly necessary...
The rise of real-world evidence
Demonstrating efficacy and value requires more than clinical trial data...
Digital health
The untapped potential to transform healthcare...