Early UK access for AstraZeneca lung cancer drug
pharmafile | December 9, 2015 | News story | | AstraZeneca, Early Access to Medicines Scheme, Tagrissa, eams, lung cancer, non small cell lung cancer, non-small cell lung cancer, osimertinib
UK patients will be among the first in Europe to have free access to AstraZeneca’s cancer drug osimertinib, after the British firm successfully applied to make the drug available through the Early Access to Medicines Scheme.
The drug has been made available for patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, through the MHRA-led scheme, which provides access to innovative medicines that have not yet been assessed by NICE.
The MHRA decision was based on early phase clinical trial data, which showed promising results in a patient group with an unmet clinical need. NHS doctors can now consider prescribing osimertinib, which will be made available free of charge by AstraZeneca for qualifying patients during the EAMS period.
Osimertinib is a targeted therapy discovered and developed by AstraZeneca scientists in the UK. It is currently undergoing accelerated regulatory review by the EMA, and would only become fully available to patients under the NHS outside of EAMS or clinical trials after a marketing authorisation is issued. The medicine is already approved and available in the US under the brand name Tagrisso following a Breakthrough Designation and Fast Track Review by the FDA.
Lisa Anson, president of AstraZeneca UK and Ireland, says: “AstraZeneca is proud that NHS patients have early access to osimertinib, which was developed in record time by our scientists in the UK as a targeted cancer medicine to meet urgent unmet medical need.
“The approval of the Scheme reflects the breakthrough clinical evidence behind osimertinib, demonstrating the potential benefit for this group of lung cancer patients. Upon granting of European marketing authorisation, we hope that the EAMS decision will result in a rapid assessment by the UK reimbursement bodies to ensure that patients can have long-term access via the NHS.”
This is the fifth EAMS to receive approval from the MHRA. Life Sciences Minister George Freeman MP, who introduced the scheme, says: “The British life sciences industry has played a leading role in the development of osimertinib and, thanks to our Early Access to Medicines Scheme, NHS patients will be among the first in Europe to have access to it. This is a win for patients, British science and AstraZeneca. Through our Accelerated Access Review we are committed to ensuring the fastest possible access to innovative and effective medicines.”
Lilian Anekwe
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