AstraZeneca lung cancer drug clears UK market access hurdle
pharmafile | September 4, 2015 | News story | Sales and Marketing | AZD9291, AstraZeneca, Early Access to Medicines Scheme, MHRA, NSCLC, eams, lung cancer, non-small cell lung cancer
AstraZeneca UK’s AZD9291 cancer treatment has been granted a Promising Innovative Medicine (PIM) designation by the MHRA.
Being awarded PIM status is the first step towards inclusion in the UK’s Early Access to Medicines Scheme (EAMS). The designation recognises that a medicinal product is a promising candidate for scheme, which aims to increase UK patient access to medicines awaiting regulatory approval where there is an unmet medical need.
The designation is for treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). Earlier this year AstraZeneca presented positive clinical trial results for AZD9291 at the American Society of Clinical Oncology conference in Chicago.
Each year, more than 44,000 people in the UK are diagnosed with lung cancer, of which about 85% to 90% of cases are NSCLC. It is estimated that around 10% of diagnosed patients have an EGFR mutation-positive NSCLC tumour, and around 60% of these will develop resistance caused by a secondary mutation known as T790M.
Commenting on the PIM award, Dr Jonathan Day, medical director at AstraZeneca UK and Ireland, says: “This is an exciting development for AZD9291 in the UK, recognising the innovation behind the medicine and the significant unmet need it aims to address. Many advanced or metastatic NSCLC tumours with the EGFR mutation initially respond to available TKI therapies, but progress on the basis of a very specific mutation – T790M. AZD9291 is specifically designed for these patients and we continue to pursue EAMS to provide access as soon as possible.”
AZD9291 achieved PIM status based on preliminary clinical data from the Phase I and II AURA study, which found an estimated median progression free survival (PFS) of 13.5 months. The drug has been been granted an accelerated assessment by the EMA, while the US FDA has granted it Breakthrough Therapy designation, Orphan Drug and Fast Track status.
This week the Novartis heart failure drug LCZ696 (sacubitril valsartan) was made available to patients through the EAMS.
Joel Levy
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