EQRx announces acceptance of MAA by EMA for sugemalimab in NSCLC

EQRx announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency has accepted for review its marketing authorization application for sugemalimab, an anti-programmed death-ligand 1 antibody, in combination with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer. The MAA is primarily supported by data from the pivotal Phase 3 GEMSTONE-302 trial, conducted by EQRx‘s partner CStone Pharmaceuticals, that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC. In 2021, sugemalimab was granted the Innovation Passport designation in the U.K. through the Innovative Licensing and Access Pathway from the ILAP partner organizations including the MHRA. The ILAP was established in early 2021 to accelerate the development of and access to medicines in the U.K.