23 September 2014
A potential new cancer treatment has become the first therapeutic to be awarded the new ‘Promising Innovative Medicine’ (PIM) designation, which could lead to fast-track access to patients.
The Early Access to Medicines Scheme (EAMS) is a new scheme launched by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in April this year. It is intended to allow patients with ‘life threatening or seriously debilitating’ conditions access to potentially useful new medicines ahead of formal approval for their use, which can take several years. The scheme is intended to benefit both seriously ill patients who lack other viable treatment options, and companies developing new medicines who could find the designation helpful in attracting investment.
The news does not mean that patients will be able to receive the therapy yet, however. PIM designation is the first of two steps in the process indicating potential eligibility for the EAMS agreed by an MHRA scientific meeting and based on preliminary clinical trial data. The MHRA assesses whether or not the product:
The second stage is an Easy Access to Medicines Scientific Opinion from the MHRA, which describes the available data, the risks and benefits of the new medicine and allows a decision to be made on whether it is eligible for early access by selected patients ahead of licensing.
The new medicine, DCVax-L, has been developed by Northwest Biotherapeutics Inc. who will continue with clinical development and hope to accrue appropriate data to allow progression to an MHRA Scientific Opinion on eligibility for the EAMS. DCVax-L is for the treatment of new and recurrent malignant gliomas and is not a classical drug but a cellular or biological therapy – in this instance what is termed a cancer vaccine intended to prime the body’s own immune defences to target and destroy tumour cells.
NorthWest’s Chief Executive Linda Powers said that the scheme offered “a very practical balance between clinical benefits and risks, through careful scientific evaluations”.
Life Sciences Minister George Freeman commented: “We want to make Britain the best place in the world to design and deliver 21st Century healthcare technologies which is central to our life science strategy. This Promising Innovative Medicine designation is the first crucial step in accelerating access to new medicines, giving real hope to patients and their families”. He also said he hoped to see more companies of all sizes and medical charities nominating products for the EAMS.