UK’s MHRA accepts MAA for sugemalimab in metastatic non-small cell lung cancer
EQRx, Inc., a new type of pharmaceutical company committed to developing and expanding access to innovative medicines for some of the most prevalent disease areas, including cancer and immune-inflammatory conditions,has announced that the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for review its marketing authorization application (MAA) for 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
The MAA is primarily supported by data from the pivotal Phase III 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 (ILAP) 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.
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