Marketing Authorization Application Accepted for Sugemalimab in Metastatic Non-small Cell Lung Cancer

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted a review of the marketing authorization application (MAA) for EQRx’s sugemalimab, an anti-programmed death-ligand 1 (PD-L1) antibody, in combination with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).

“With the acceptance of this application, we now have two investigational therapies under review with the MHRA in non-small cell lung cancer, which affects about 40,000 people annually in the UK and is a leading cause of cancer death,” said Melanie Nallicheri, president and chief executive officer of EQRx, in a press release. “This significant milestone is a step toward our goal of getting our medicines to patients and delivering on our mission of increasing access to impactful treatments."

The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.

Sugemalimab was granted the Innovation Passport designation in the UK in 2021 through the Innovative Licensing and Access Pathway (ILAP) from the ILAP partner organizations, including the MHRA.

Source: EQRx