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A new lung cancer medicine is to be made available to patients in the UK following its acceptance for inclusion in the Early Access to Medicines Scheme (EAMS).
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a positive scientific opinion authorising the addition of alectinib to the scheme as a first-line treatment for adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Sold under the brand name Alecensa, the therapy was approved by the European Commission in February this year for use across the EU as a treatment for adults with ALK-positive NSCLC who have previously been treated with crizotinib. However, it has not been ratified for use among patients who have not yet received any treatment.
European regulators are currently assessing whether to authorise the drug in this additional indication, but data from clinical trials have already offered evidence that treatment-naive patients receiving this drug can achieve significant improvements in progression free-survival when compared to the current standard of care.
This is a potentially important benefit, as many patients with ALK-positive NSCLC develop resistance to the current standard of care within a year of treatment, while around 60 per cent see the cancer spread to the central nervous system.
The MHRA decision once again underlines the benefits offered by the government's EAMS initiative, which allows patients with life-threatening or seriously debilitating conditions to gain early access to medicines that have not yet been formally approved while the assessment process is still ongoing.
To be eligible for EAMS inclusion, there must be a clear unmet medical need that the drug can be shown to address, while the MHRA must issue a scientific opinion validating the positive risk/benefit profile of the medicine in question, based on the clinical evidence available at the time.
Written by James Puckle
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