Please login to the form below

Not currently logged in
Email:
Password:

Roche’s lung cancer drug Alecensa wins EU approval

Monotherapy conditionally approved as second-line NSCLC treatment
Roche

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

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Langland

Langland, a Publicis Health company, is the only health communications agency that thinks further across Clinical Trial Experience, Medical Strategy...

Latest intelligence

Deep 6 AI: the smart software breathing new life into clinical trials
Fishawack Health interviews Wout Brusselaers, the Deep 6 AI CEO using artificial intelligence to solve one of the greatest barriers stagnating healthcare innovation—clinical trial recruitment and retention....
COVID-proof: How Teams are Creating Launch Intensity thru Adversity
Now that the game has changed, how are marketers shifting their launch behaviour? We've identified 5 common observations from effective teams....
5 ways that lockdowns and restrictions could be affecting our allergies
Over this last year, lockdowns and restrictions have led to changes in the day-to-day environments for people across the world. For Allergy Awareness week, we wanted to explore some of...