Access to medicines
Osimertinib given green light under UK’s early access to medicines scheme
Source: Centre Jean Perrin, ISM / Science Photo Library
A new treatment for locally advanced or metastatic non small-cell lung cancer (NSCLC), osimertinib, is being made available to patients under the UK government’s early access to medicines scheme (EAMS).
The unlicensed product was given a positive scientific opinion by the Medicines and Healthcare products Regulatory Agency (MHRA) in recognition of its potential to address an unmet clinical need.
The drug will be available under the scheme to adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC whose disease has progressed, despite EGFR tyrosine kinase inhibitor therapy.
The MHRA based its decision on the results of two clinical trials involving 411 patients with EGFR T790M mutation-positive lung cancer, whose tumour had grown despite treatment. The studies found that 61% of patients treated with osimertinib experienced some tumour shrinkage and in some other patients the cancer did not get any bigger. Preliminary data also showed that osimertinib may improve the symptoms of the disease and the quality of life of patients.
The medicines safety watchdog says that most of the adverse reactions to the drug were of “low severity”, and the drug’s benefits to this group of patients who have “very limited treatment options” outweighed the risks.
The MHRA’s decision means that doctors will have access to benefit and risk information about the drug, which they can use to choose whether to prescribe it.
Osimertinib is manufactured by AstraZeneca.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20200276
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