AstraZeneca’s non-small cell lung cancer drug AZD9291 has cleared the first stage of a two-step process for being included in the UK’s Early Access to Medicine Scheme.
The Medicines and Healthcare Products Regulatory Agency has awarded the drug Promising Innovative Medicine status as a treatment for locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC.
The industry-funded EAMS is designed to provide patients with life-threatening and seriously debilitating conditions much faster access to innovative and promising new drugs, before they have received full regulatory approval, as soon as the Medicines and Healthcare products Regulatory Agency has signalled that the benefits outweigh the risks.
PIM designation is the first stage in the process, the second is attaining an EAMS Scientific Opinion from the MHRA, if the quality, safety and efficacy data provided in support of the application is sufficient to support a positive benefit/risk balance and added clinical value.
More than 44,000 people in the UK are diagnosed with lung cancer every year, of which 85%-90% are NSCLC. Around 10% of diagnosed patients will carry an EGFR mutation-postive NSCLC tumour, and around 60% of these will develop resistance caused by a secondary mutation known as T790M.
AZD9291’s PIM is based on preliminary clinical data from the Phase I and II AURA study, which showed that, at an 80mg dose, treatment with the drug achieved an 61% objective response rate; median duration of response of 12.4 months; and an estimated median progression free survival of 13.5 months, AZ notes.
On the safety side, the all-cause most common adverse events at 80mg (any grade) were rash (38%) and diarrhoea (36%).