Mirati Therapeutics has received conditional marketing authorisation approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its advanced non-small cell lung cancer (NSCLC) therapy, Krazati (adagrasib).
Krazati has been approved as a monotherapy to treat adult patients with advanced NSCLC with KRASG12C mutation and who have progressive disease after previous therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.
Adagrasib is designed to meet the challenge of KRASG12C by maintaining consistent target inhibition, which is vital for addressing KRASG12C-mutated cancers.
This is particularly important as the KRASG12C protein regenerates every 24-48 hours.
The therapy has demonstrated its ability to enter the central nervous system (CNS), a crucial factor considering the frequent occurrence of CNS metastases in NSCLC, which often leads to a poor prognosis.
The KRYSTAL-1 open-label Phase I/II multiple-expansion cohort study assessed adagrasib as a single agent and along with other anti-cancer therapies in patients with advanced solid tumours harbouring the KRASG12C mutation.
Mirati Therapeutics chief medical officer Alan Sandler said: “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.”
Most lung cancers fall into two categories, including NSCLC, which constitutes around 85% of cases, and small cell lung cancer (SCLC), which makes up about 15% of cases.