Roche’s lung cancer drug Alecensa (alectinib) has been approved for early access in the UK under an MHRA scheme that allows it to reach patients prior to gaining a European licence.
The oral drug has been developed for people with non-small cell lung cancer (NSCLC) whose tumours are identified as ALK-positive, without the need for prior chemotherapy.
The UK will now be the first country in Europe to access Alecensa, following the MHRA’s positive scientific approval under its Early Access to Medicines Scheme (EAMS).
The scheme – which was introduced in 2014 – allows patients and doctors access to ‘innovative’ treatments for serious medical conditions where there is a clear current unmet medical need.
Roche UK’s medical director Rav Seeruthun said: “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.”
In the UK, more than 45,000 people are diagnosed with lung cancer annually, with approximately 4-5% patients that are identified with advanced NSCLC are ALK-positive.
Seeruthun added: “Our mission is to discover treatments that are beyond the standard of care, and we work tirelessly to be able to make them available to patients in the UK.”
The approval was based on the back of the ALEX study, an open-label, randomised phase III head-to-head trial which compared the efficacy and safety between alectinib and crizotinib in patients who had not previously received treatment.
Data from the study showed that patients taking Alecensa had significantly prolonged progression-free survival when compared with Pfizer’s Xalkori (crizotinib), reducing risk of progression/death by 53%.
Alecensa is still being assessed for marketing authorisation by the EMA, and Roche said it expects an official license later this year.
The Swiss pharma firm said it would “continue to work collaboratively and flexibly with NICE and NHS England to achieve sustained access for alectinib”.