Novartis has joined Cancer Research UK as the second major pharmaceutical company to partner in the charity’s determining extended therapeutic indications for existing drugs in rare molecularly-defined indications using a national evaluation (DETERMINE) trial.
The trial was launched in November this year and enrolled paediatric and adult patients diagnosed with any rare cancer type with its focus on evaluating the multi-drug, precision medicine for rare cancers. The study was launched by Cancer Research UK’s Centre for Drug Development, the University of Manchester and Roche.
With Novartis on board, Roche will continue providing access to cancer treatments via the study, supported by sponsorship and management from the Centre for Drug Development and trial leadership from the University of Manchester.
The DETERMINE trial is focused on discovering whether existing drugs – including those which are licensed for more common types of cancer – could also benefit patients diagnosed with rare cancer types that the drug is not currently licensed for.
Eligible patients will have taken part in genetic screening and will have had one of the particular genetic mutations detected in their cancer that can be targeted by a drug on the trial.
Cancer Research UK has encouraged other pharmaceutical or biotechnology companies with targeted oncology agents which have been licensed or are close to being licensed, with the trial offering a chance to assess their agent in rare indications not included in their licence.
With more companies involved, further access will be opened up to even more patients with rare cancers, offering them a chance of finding a potentially beneficial treatment.
Any treatment that appears to be benefitting patients on the trial will be submitted for review by the Cancer Drugs Fund (CDF).
It is then down to a decision made by the CDF, working in tandem with NHS England Clinical Policy team, as to whether a period of data collection in the CDF is appropriate in order to assess if the drug could be used as a routine treatment option on the NHS for patients with this cancer type.
The Christie NHS Foundation Trust has been the first site to host the trial, with other sites soon to follow. This includes the Royal Marsden NHS Foundation Trust, the University of Glasgow and the University of Birmingham, as well as facilities across the entire adult and paediatric Experimental Cancer Medicine Centres network.
Dr Gerrit Zijlstra, chief medical officer, Novartis UK, said: “At Novartis we are committed to reimagining medicine, and we are delighted to partner with Cancer Research UK and the University of Manchester to explore further potential of our innovative treatments in changing outcomes for adults, teenagers and children with rare cancers.”