The National Institute for Health and Care Excellence published final draft guidance on Thursday recommending use of Roche's Rozlytrek (entrectinib), via the Cancer Drugs Fund (CDF), for adults and children 12 years and older, with advanced NTRK fusion-positive solid tumours, who have no satisfactory treatment options. The regulator noted that patients will have access to the NTRK inhibitor once a marketing authorisation has been granted.
Meindert Boysen, director of the centre for health technology evaluation at NICE, noted that "while the evidence suggests that solid tumours with NTRK gene fusions shrink in response to [Rozlytrek], further trial data is needed." Boysen added that "joint working" between NICE, NHS England and the company will give patients access to the drug "while more data is collected to address any clinical uncertainties."
According to the final appraisal document, NICE said that it is uncertain how well Rozlytrek works because it has not been compared with other treatments in trials. The agency added that while there is evidence that Roche's drug works well for some types of NTRK fusion-positive tumours, there is little or no evidence for other types. Meanwhile, NICE indicated that the cost-effectiveness estimates for the drug "are uncertain because of limitations in the data," with some estimates higher than what would normally be considered an acceptable use of NHS resources.
Second histology-independent drug
Boysen added that the "decision is another positive step forward for cancer care driven by genomics." Earlier this year, NICE also recommended use of Bayer's oral TRK inhibitor Vitrakvi (larotrectinib) via the CDF for advanced NTRK fusion-positive solid tumours in adult and paediatric patients, if the disease is locally advanced, metastatic or surgery could cause severe health problems, and if they have no satisfactory treatment options.
Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended conditional approval of Rozlytrek for the treatment of patients whose solid tumours have a NTRK gene fusion, or patients with ROS1-positive advanced non-small-cell lung cancer. The drug gained clearance last year in Japan and the US.
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