MHRA: sotorasib and liver monitoring

What was announced

The MHRA says that, following an update to the summary of product characteristics for sotorasib (Lumykras), healthcare professionals should carry out more frequent liver function testing in patients who received immunotherapy recently, within the previous three months, before starting sotorasib. The Safety Roundup was published on 25 August 2026.

What it means

The MHRA cites a review of clinical data that found a higher rate of liver injury (hepatotoxicity) in this group than in patients who started sotorasib more than three months after their last immunotherapy dose or who never had immunotherapy. It adds that recent immunotherapy before sotorasib may also be a risk factor for interstitial lung disease, a group of conditions that cause scarring and inflammation in the lungs.

The MHRA says sotorasib should be withheld in patients with severe liver injury, or if interstitial lung disease is suspected, and points clinicians to the summary of product characteristics for monitoring details. The site's lung cancer page gives background.