Adult patients in the UK with PD-L1 positive, unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) will be able to have early access to atezolizumab in combination with nab-paclitaxel.
Roche, the manufacturer of atezolizumab, is funding access to the treatments, following a positive scientific opinion by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), under the Early Access to Medicines Scheme (EAMS).
Under the terms of the EAMS agreement, TNBC patients whose tumours have PD-L1 expression ≥1% and who have not received prior chemotherapy for metastatic disease will be eligible for the scheme. An estimated 15% of breast cancers in the UK are classed as TNBC, a small proportion of whom could be eligible to receive atezolizumab.
Since 2014, the EAMS has aimed to give people access to promising new drugs that are not yet licensed. It is only available for therapies that could benefit people with life-threatening or seriously debilitating conditions and when treatment options are very limited. The EAMS is run by the MHRA.
TNBC is the term used to describe breast cancers that lack three types of receptors. They do not express oestrogen- or progesterone-receptors and do not overexpress human epidermal growth factor receptor 2 (HER2).
Lesley Hugo, Breast Cancer Franchise Lead at Roche said: “People with TNBC currently have poor clinical outcomes and treatments are limited, with chemotherapy being the main therapeutic option. Roche has worked closely with healthcare bodies to deliver access for patients to the innovative medicine atezolizumab as quickly as possible.”