NMS Group
June 15, 2020


By Emma Morriss, Pharmafield

The National Institute for Health and Care Excellence (NICE) has approved a new rare lung cancer treatment.

NICE has published its decision to grant a positive final appraisal document (FAD) for the use of Roche’s Rozlytrek®▼ (entrectinib) in adults with ROS1-positive 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. Currently there is a lack of treatments for ROS1-positive NSCLC, especially for people whose lung cancer has spread to the brain.

Roche presented data from three clinical trials, which show that treatment with Rozlytrek® is effective at shrinking tumours, and slowing overall progression of the disease (median of 16.8 months progression-free with entrectinib), including in patients who have developed brain tumours.

Additionally, entrectinib meets NICE’s criteria to be considered a life-extending, end-of-life treatment. Evidence suggests that the treatment could be expected to extend life by more than three months compared to pemetrexed with platinum chemotherapy, which is a common treatment for NSCLC.

Karen Lightning-Jones, Head of Personalised Healthcare and Strategic Partnerships, Roche Products Limited said: “Today’s news follows many years of dedication and hard-work by our scientists and the wider scientific community. It 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. We are currently working with regulatory authorities and NICE to ensure that relevant UK patients also benefit from our first tumour agnostic treatment. Our vision is to ensure that people in the UK live longer and healthier lives, and today’s news shows how we are advancing science to achieve this.”

Entrectinib is taken orally, once daily throughout the course of treatment. It is estimated that this treatment will be made available to around 412 people in England.

Entrectinib does not currently have a marketing authorisation in the UK for treating ROS1-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had ROS1 inhibitors. It will be made available on the NHS only if and when it receives its marketing authorisation for this indication. The anticipated marketing authorisation is expected in August 2020. The appeal period for this appraisal will close at 5pm, Monday 29 June 2020.


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