MHRA approves drug for lung cancer with limited therapy options

Non-small cell lung cancer

The UK regulator has approved a new treatment for non-small cell lung cancer (NSCLC) in adults that has a mutation and produces a rare protein called KRAS G12C.

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Krazati (adagrasib) to treat patients whose disease is advanced or has spread to other parts of the body, and where previous treatments have failed.

The drug was recommended for approval in Europe by the CHMP in July 2023.

More than 43,000 people are diagnosed with lung cancer every year in the UK. Non-small cell lung cancer is the most common form of lung cancer, accounting for approximately 80-85% of cases. Of patients with NSCLC, it is estimated that 13-14% produce the KRAS G12C protein.

The KRAS G12C protein causes the cancer cells to grow out of control. Krazati attaches to the protein and stops it from working, which may slow down or stop the growth of the cancer.

“Fourteen percent of people living with NSCLC harbour the KRASG12C mutation yet there are limited targeted treatment options for patients with this devastating disease,” said Dr Shobhit Baijal, Consultant Medical Oncologist of The University Hospital Birmingham. “The expansion of treatment options for NSCLC benefits patients and clinicians alike. As someone intensively involved in the management of lung cancer patients, I look forward to Krazati being available for use in clinical practice.”

Krazati is available in 200mg tablet form, with the recommended dose of three tablets taken at the same times twice a day.

“Krazati offers a compelling therapeutic option for patients with previously treated locally advanced NSCLC with a KRASG12C mutation. MHRA’s authorisation is a significant step towards improving the options available for patients and clinicians in Great Britain,” said Alan Sandler, Chief Medical Officer, Mirati Therapeutics.

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