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EQRx receives MHRA marketing approval for sugemalimab

EQRx – a focused on expanding access to innovative medicines – has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted a marketing authorisation application (MAA) for sugemalimab.

The therapy isan 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).

The application is mainly supported by data from the pivotal phase 3 GEMSTONE-302 trial, undertaken by EQRx’s partner CStone Pharmaceuticals. The study evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.

Last year, sugemalimab was granted the Innovation Passport designation in the UK through the Innovative Licensing and Access Pathway (ILAP) from the ILAP partner organisations including the MHRA. The ILAP was established in early 2021 to accelerate the development of and access to medicines in the UK.

Melanie Nallicheri, president and chief executive officer at EQRx, reflected: “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.”

She added: “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.”

Sugemalimab is a monoclonal antibody targeting programmed death-ligand which is under investigation in several ongoing clinical trials, including studies in relapsed or refractory extranodal natural killer/T-cell lymphoma.

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