Specifically, Sanofi and Regeneron Pharmaceuticals, Inc . They announced that the Food and Drug Administration (FDA) US yielded characterization Important Innovative Therapy (Breakthrough Therapy) in cemiplimab (REGN2810) for the treatment of adults with metastatic squamous cell skin carcinoma (CSCC) and adults with locally advanced and unresectable squamous cell skin carcinoma ( CSCC), the second most lethal type of skin cancer after melanoma.
Cemiplimab is an investigational human monoclonal antibody targeting PD-1 protein.
Sanofi and Regeneron have reported positive, preliminary results for cemiplimab that came from two extension groups involving 26 patients with advanced squamous cell carcinoma of the skin(CSCC) in a Phase 1 clinical study involving approximately 400 patients. EMPOWER-CSCC 1, a Phase 2, potentially pilot, open-label single strand study of cemiplimab, is in the process of importing patients with metastatic squamous cell carcinoma (CSCC) and locally advanced and unresectable squamous cell carcinoma of the skin (CSCC). Cemiplimab is being developed jointly by Sanofi and Regeneron as part of a global partnership agreement. Awaiting the results of the data, companies expect to submit an Application for a Biological Product Permit for cemiplimab to the US Food and Drug Administration (FDA) in the first quarter of 2018.
Skin squamous cell carcinoma (CSCC) is the second most common type of skin cancer in the United States. Although squamous cell carcinoma has a good prognosis if diagnosed in time, it can be particularly aggressive when it develops in advanced stages. Patients at this stage can be deformed due to multiple interventions to remove tumors from the surface of the skin, head, neck, throat and other parts of the body. Streptococcal carcinoma is responsible for most deaths of patients with skin cancer other than melanoma.
The designation "Breakthrough Therapy" was created to expedite the development and evaluation of drugs for the treatment of serious or life-threatening conditions. Medicines that qualify for this qualification should show reliable evidence of significant improvement in a clinically significant endpoint compared to available treatments or placebo if no treatment is available. The rating includes all the features of the Fast Track program as well as more intensive guidance and discussion with the FDA. The designation "Important Innovative Treatment" differs both from the Rapid Acceptance Procedure and from the Priority Assessment Process,
Cemiplimab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
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