Roche’s Alecensa gets green light for early access scheme

UK patients with a rare form of lung cancer will be able to access Roche’s Alecensa without the need for prior chemotherapy before official approval is obtained, following its inclusion in the country’s Early Access to Medicines Scheme (EAMS).

The Medicines and Healthcare products Regulatory Agency has issued a positive Scientific Opinion allowing use of the drug on the scheme for first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), while it is being assessed for marketing authorisation by European regulators.

Data from the ALEX study showed that treatment naiive patients taking Alecensa (alectinib) had significantly prolonged progression free survival (PFS) when compared with the current standard of care, crizotinib, with the risk of progression/death reduced by 53 percent.

"We are delighted that we are able to make alectinib available to patients with this rare type of lung cancer in the UK via EAMS," said Rav Seeruthun, medical director of Roche Products Ltd, commenting on the decision. "We will continue to work collaboratively and flexibly with NICE and NHS England to achieve sustained access for alectinib."

Alecensa was approved for use within the European Union in February this year to treat adults with ALK positive NSCLC who have previously been treated with crizotinib.

Roche has previously noted that most patients with ALK-positive NSCLC develop resistance to the current standard of care within one year of treatment, and around 60 percent will develop metastases in the central nervous system, highlighting the need for new treatment options.