National Institute for Health and Clinical Excellence (NICE)
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Targeted treatment for rare form of aggressive lung cancer gets NICE approval

Mobocertinib recommended as a treatment for a rare and aggressive form of lung cancer

More than 100 people are set to benefit after NICE published final draft guidance recommending from a new targeted therapy for advanced lung cancer yesterday (Wednesday, 16 November).

Mobocertinib (Exkivity, Takeda) is a treatment for people with the epidermal growth factor receptor (EGFR) exon 20 insertion gene mutation-positive form of advanced non-small-cell lung cancer (NSCLC), who have already received platinum-based chemotherapy.

There is currently no standard treatment for exon 20 insertion mutation-positive NSCLC so the treatment addresses a clear unmet clinical need for patients. This rare and aggressive form of lung cancer is more common in women, people from East Asian family backgrounds and non-smokers, compared with NSCLC with other EGFR mutations.

Mobocertinib, taken as four capsules per day at home, works by specifically targeting the mutation to slow the growth of cancer cells, with clinical trials indicating it is well tolerated by patients.

Indirect comparisons using real-world evidence on immunotherapies and docetaxel with or without nintedanib, suggest that mobocertinib increases how long people live. The independent committee heard that mobocertinib was highly likely to lead to a gain in overall survival of more than three months.  

The company has a confidential commercial arrangement through a patient access scheme, that makes mobocertinib available to the NHS with a discount.

The treatment was licenced through Project Orbis, an international programme to review and approve promising cancer drugs helping patients access treatments faster.

This is the 19th lung cancer drug recommended by NICE in the last three years, with a total of around 18,000 people eligible to receive these treatments.

Helen Knight, interim director of medicines evaluation at NICE, said: “I’m delighted that we have been able to recommend this innovative treatment for patients in England with this rare and aggressive form of lung cancer.

“This is the first treatment approved by NICE that targets this specific gene mutation in people with advanced non-small-cell lung cancer. The evidence shows it not only extends people’s lives but also extends how long people have before their cancer gets worse.

“We are determined to drive ground-breaking treatments such as this into the hands of health and care professionals. This treatment was licensed through Project Orbis and we know how crucial collaborations with our colleagues in NHS England, MHRA and other organisations are to bringing innovative treatments to patients as rapidly as possible.”

Read the full draft final guidance on the NICE website.

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