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

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Bedrock Healthcare Communications

Bedrock Healthcare Communications is a privately owned, award winning communications agency that creates and delivers highly effective, insight driven medical...

Latest intelligence

PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...
What Would Jeremy Do? : Assessing the impact of a Corbyn-led Labour government
GK Strategy are delighted to announce the launch our latest briefing paper entitled ‘What Would Jeremy Do? Assessing the impact of a Corbyn-led Labour government’....

Infographics