NICE backs Rozlytrek for subset of NSCLC patients

NICE has published final draft guidance backing NHS use of Roche's Rozlytrek (entrectinib) as a treatment option for ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

ROS1 is a rare mutation found in fewer than 2% of NSCLC cases, for which there is currently a lack of treatment options, especially for those patients where the disease has spread to the brain.

In clinical trials, Rozlytrek was shown to be effective at shrinking tumours and holding back overall disease progression (median of 16.8 months progression-free), including in patients who have developed brain tumours, NICE noted.

The drug also meets the Institute's criteria to be considered a life-extending, end-of-life treatment, as evidence suggests it could extend life by more than three months compared to pemetrexed with platinum chemotherapy, a standard treatment for NSCLC.

NICE's green light for Rozlytrek comes just days after the European Medicines Agency’s human medicines committee's said it backed the drug's approval, under a conditional marketing authorisation.

Karen Lightning-Jones, head of Personalised Healthcare and Strategic Partnerships, Roche Products Limited, said the Institute's endorsement of the drug “represents an important milestone for patients who previously had limited treatment options for ROS1+ NSCLC, a rare form of lung cancer.

“The pharmaceutical industry is often criticised for delaying access to new treatments. We are showing that there is a different way, and are proud to have again worked in partnership with NHSE and NICE to fast-track access.”

It is estimated that this treatment will be made available to around 412 people in England.