Roche’s Alecensa accepted for Early Access to Medicines Scheme

Roche has announced that its cancer therapy Alecensa has been accepted for inclusion in the UK's  Early Access to Medicines Scheme (EAMS).

The Medicines and Healthcare Products Regulatory Agency has issued a positive scientific opinion validating the availability of Alecensa through EAMS as a first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

EAMS was established as a means of providing UK patients with early access to medicines that have not yet received formal regulatory approval while assessment processes are still going on.

Data from a phase III trial called ALEX have shown that treatment-naive patients receiving Alecensa experienced significantly prolonged progression-free survival rates when compared with the current standard of care.

Rav Seeruthun, medical director of Roche Products, said: "We will continue to work collaboratively and flexibly with NICE and NHS England to achieve sustained access for alectinib."

Alecensa was approved in Europe in February as a treatment for ALK-positive NSCLC patients who have previously been treated with crizotinib.

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