NICE greenlights Roche’s Rozlytrek for ROS1+ advanced non-small cell lung cancer

pharmafile | June 15, 2020 | News story | Sales and Marketing NICE, Roche, Rozlytrek, UK, lung cancer 

Roche’s Rozlytrek (entrectinib) has secured recommendation for NHS use in England and Wales after NICE backed the drug in final draft guidance for the treatment of ROS1-positive, advanced non-small cell lung cancer (NSCLC) in adult patients who have not previously received ROS1 inhibitors for the condition.

The ROS1 mutation is rare among NSCLC patients, accounting for about 2% of all cases of the disease. It’s estimated that around 412 patients will benefit from the decision in England

This latest approval will go a long way to providing a treatment option for patients in a condition with current unmet need, particularly in cases where the cancer has spread from the lungs to the brain.

NICE’s decision was based on clinical trial data showing that Rozlytrek demonstrated a median progression-free survival rate of 16.8 months and improved overall survival by over three months compared to standard of care treatment for the condition, the combination of platinum chemotherapy with Eli Lilly’s Alimta (pemetrexed). Participants tested included those whose tumours had metastasised to the brain.

“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,” commented Karen Lightning-Jones, Head of Personalised Healthcare and Strategic Partnerships at Roche. “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.”

NICE’s decision follows on the heels of the conditional marketing approval recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use for Rozyltrek in the same indication, and as a monotherapy in solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

Matt Fellows

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