MHRA authorises new treatment for rare lung cancer

A new medicine to treat adults with non-small cell lung cancer (NSCLC) with a rare mutation called KRAS^G12C has been authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

According to the MHRA, Mirati Therapeutics B.V.’s Krazati^® (adagrasib) can be used in this indication in individuals who have an advanced form of the disease, or it has spread to other parts of the body. In addition to being indicated in those with progressive disease, Mirati Therapeutics shared that the treatment is also authorised for patients with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.

New cancer therapy for KRAS^G12C-mutated NSCLC

In a statement on its decision, the MHRA highlighted that the KRAS^G12C protein causes the cancer cells to grow out of control.

As a highly selective and potent oral small-molecule inhibitor of KRAS^G12C, Mirati Therapeutics’ adagrasib is optimised to sustain target inhibition. This could be important to treat KRAS^G12C-mutated cancers, as the KRAS^G12C protein regenerates every 24−48 hours, the company stated, elucidating research published in 2020 in the journal Cancer Discovery. Mirati Therapeutics also shared in a press release that adagrasib has shown clinically to penetrate the central nervous system.

Adagrasib is available for eligible NSCLC patients as a 200mg oral tablet. It provides a “potential best-in-class treatment to qualified patients,” according to Dr Alan Sandler, Chief Medical Officer of Mirati Therapeutics, Inc.

Dr Shobhit Baijal, Consultant Medical Oncologist of The University Hospital Birmingham, UK highlighted statistics from the aforementioned 2020 Cancer Discovery paper and a 2022 paper from Clinical Cancer Research: “Fourteen percent of people living with NSCLC harbour the KRAS^G12C mutation yet there are limited targeted treatment options for patients with this devastating disease.”

Therefore, “KRAZATI offers a compelling therapeutic option for patients with previously treated locally advanced NSCLC with a KRAS^G12C mutation. MHRA’s authorisation is a significant step towards improving the options available for patients and clinicians in Great Britain,” Dr Sandler continued.