Novartis’ investigational lung cancer drug Zykadia (ceritinib) been awarded Promising Innovative Medicine status in the UK, completing the first stage of the country’s Early Access to Medicines Scheme.
The PIM status regards the treatment of adult patients with previously treated anaplastic lymphoma kinase positive advanced non-small cell lung cancer (ALK+ NSCLC), whose treatment options are currently very limited.
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.
Attaining PIM is the first stage in this two-tiered process; in stage two, the Agency issues an EAMS Scientific Opinion 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.
In Europe, regulators recently recommended conditional clearance for the drug in patients who have already been treated with Pfizer’s Xalkori (crizotinib), the current standard of care. Not all patients respond to treatment with this drug, and disease progression typically occurs in any case, leaving patients in dire need of a new treatment option.
Zycadia has also already picked up an accelerated approval in the US for the same indication, based on a trial including 163 patients with metastatic ALK+ NSCLC who were previously treated with Xalkori that showed an overall response rate (tumour shrinkage) of 54.6% and a median duration of response of 7.4 months.