European CHMP recommends approval of sotorasib for the treatment of KRAS G12C mutation non-small cell lung cancer (NSCLC)
The CHMP has recommended the granting of a conditional marketing authorisation for the KRAS G12C inhibitor, based on the observed objective response rate and response duration in patients with KRAS G12C-mutated NSCLC who had disease progression after receiving prior therapy.
Source:
European Medicines Agency
SPS commentary:
A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is expected to provide comprehensive clinical data at a later stage.