Roche's Rozlytrek (entrectinib) is the second histology independent drug to be recommended by NICE for use on the Cancer Drugs Fund (CDF), following a green light for Bayer's Vitrakvi (larotrectinib) earlier this year.
As a histology independent treatment, the drug targets all solid tumours that have a certain genetic mutation (a neurotrophic tyrosine receptor kinase (NTRK) gene fusion), regardless of where the cancer originated in the body.
As NICE notes, this is particularly beneficial to patients with some rare types of cancer where treatment options are currently limited.
Between 600-700 people have solid tumours with NTRK gene fusions. For those aged 12 years and older who have no satisfactory treatment options, treatment with Rozlytrek will be funded via the CDF, once a European marketing authorisation is granted.
The EMA's human medicines committee recently backed the approval of the drug as monotherapy for adults and paediatric patients 12 years of age and older, with solid tumours expressing an NTRK gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor.
“People across England will be among the first in Europe to benefit from a new generation of medicine that targets tumours based on their genetic make-up, rather than where they are in the body,” noted Karen Lightning-Jones, head of Personalised Healthcare and Strategic Partnerships, Roche Products Limited.
“We are proud to have worked in partnership with NHSE, NICE and the Accelerated Access Collaborative, to fast-track access. We look forward to the English Genomic Medicine Service being able to operate at full capacity and help identify those patients who may benefit from entrectinib."
Meindert Boysen, deputy chief executive and director of the centre for health technology evaluation at NICE, said the decision to approve CDF funding for the drug “is another positive step forward for cancer care driven by genomics. Treatments like entrectinib, have the potential to revolutionise how we treat cancers by targeting a genetic mutation that activates tumour growth irrespective of the solid tumour’s location.”