The UK drugs regulator the MHRA has granted a ‘promising innovative medicine’ for its new lung cancer drug Zykadia (ceritinib).
Specifically, the pill has been designated as a promising innovative medicine (PIM) for the treatment of patients with previously treated anaplastic lymphoma kinase positive advanced non-small cell lung cancer (ALK+ NSCLC).
PIM is the first step towards inclusion on the Early Access to Medicines Scheme (EAMS), a new UK project run by the MHRA that aims to give patients with life-threatening conditions access to unlicensed medicines when there is a clear medical need.
Margaret Dean, Novartis Oncology general manager in the UK and Ireland, said: “We’re delighted that ceritinib is now one of only a handful of medicines that have been granted a PIM designation since the inception of the Early Access to Medicines Scheme.”
Zykadia is not the only drug for this indication as Pfizer’s Xalkori (crizotinib) is already on the UK market – and NICE-approved – for ALK-positive lung cancer. This form of the disease affects around 5% of all NSCLC patients – Xalkori made $350m in sales last year but is expected to reach sales of $1bn by 2020.
Novartis will hope to start competing with Pfizer earlier than expected – the next stage in the process is for the Swiss firm to apply to the MHRA to provide a scientific opinion on the benefit/risk balance of ceritinib, based on the data available.
Dean said that there can “often be a lengthy time lag” between the submission of marketing authorisation of a medicine and its review by NICE.
But under the EAMS process, when it comes to a NICE appraisal things should also be sped up here too. An appraisal from the Institute can take anything from nine months to a year, depending on whether the watchdog is minded to find it cost-effective from the start, which could slow down the entire EAMS process.
In a statement the MHRA said that: “Medicines which have been developed through the Early Access Medicines Scheme will, following granting of a marketing authorisation, be appraised by NICE for routine use on the basis of the evidence collected in the earlier stages of the scheme.”
The BioIndustry Association explained to PME: “We understand the thinking is that with NICE, having earlier knowledge of the product and access to evidence from the earlier stages of the EAMS process, this will speed up the NICE appraisal at the point of marketing authorisation.”
Zykadia is already licensed for use in the US and was one of the first medicines to be granted Breakthrough Therapy designation by the FDA. It has also been recommended for use in Europe by the EMA – a final decision is expected in May.
The drug’s acceptance onto the scheme follows hot on the heels of a PIM designation for Merck & Co’s melanoma drug Keytruda (pembrolizumab), which was accepted for an accelerated review in February.