AstraZeneca's Tagrisso (osimertinib) has become the first drug to be supported by the UK's newly-reformed Cancer Drugs Fund (CDF).
Now overseen by the National Institute for Health and Care Excellence (NICE), the CDF will make Tagrisso available to NHS England patients on a 'managed access' basis.
This will continue while NICE awaits further data on the first-in-class non-small cell lung cancer (NSCLC) treatment, which won European approval in February.
AstraZeneca UK and Ireland country president Lisa Anson said: “We are very proud that NHS patients in England now have access to osimertinib.
“This is a great example of partnership between clinicians, AstraZeneca, the Department of Health, NICE, NHS England and other stakeholders to ensure that UK patients gain access to an innovative medicine while further data are gathered.”
Cost-effectiveness watchdog NICE has yet to recommend Tagrisso for general NHS use, and is currently awaiting the results of ongoing studies into the NSCLC drug's long-term effectiveness.
In the meantime, the recently-relaunched CDF will give around 300 patients across England and Wales access to Tagrisso as a second-line treatment for advanced metastatic EGFR T790M mutation-positive NSCLC.
Professor Carole Lonson, director of NICE's health technology evaluation centre, said: “For the first time, we are able to give patients access to a promising new cancer treatment while more evidence is gathered on its effectiveness. This is the system working as it should.”
Tagrisso is designed to target both the EGFR mutation, which triggers cancer growth, and the T790M mutation, which creates resistance to existing NSCLC treatments, such as Roche and Astellas' Tarceva (erlotinib), AZ's Iressa (gefitinib) and Boehringer Ingelheim's Giotrif (afatinib).
In two AURA phase II trials, 66% of patients with both mutations saw their tumours shrink, with an average progression free survival of 11 months.
AZ's drug had previously been made available to UK patients through an early access scheme, funded entirely by the pharma company, between December 2015 and February 2016 ahead of EU marketing authorisation.