FDA begins priority review of cemiplimab for advanced cutaneous squamous cell carcinoma

 

The Food and Drug Administration will conduct a priority review of cemiplimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (SCC), the companies developing the treatment announced on April 30.

Cemiplimab, a human monoclonal antibody being developed by Regeneron Pharmaceuticals and Sanofi, targets the checkpoint inhibitor programmed cell death protein-1 (PD-1). The drug was previously granted Breakthrough Therapy status by the FDA in September 2017.

The Biologics License Application submission to the FDA is based on data from the phase 2, single-arm, open-label EMPOWER-CSCC 1 clinical trial in patients with advanced cutaneous SCC, as well as phase 1 data from two cutaneous SCC expanded cohorts.

No safety and efficacy data are available for cemiplimab at this time.

Find the full press release on the Regeneron website.

[email protected]

 

The Food and Drug Administration will conduct a priority review of cemiplimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (SCC), the companies developing the treatment announced on April 30.

Cemiplimab, a human monoclonal antibody being developed by Regeneron Pharmaceuticals and Sanofi, targets the checkpoint inhibitor programmed cell death protein-1 (PD-1). The drug was previously granted Breakthrough Therapy status by the FDA in September 2017.

The Biologics License Application submission to the FDA is based on data from the phase 2, single-arm, open-label EMPOWER-CSCC 1 clinical trial in patients with advanced cutaneous SCC, as well as phase 1 data from two cutaneous SCC expanded cohorts.

No safety and efficacy data are available for cemiplimab at this time.

Find the full press release on the Regeneron website.

[email protected]

 

The Food and Drug Administration will conduct a priority review of cemiplimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (SCC), the companies developing the treatment announced on April 30.

Cemiplimab, a human monoclonal antibody being developed by Regeneron Pharmaceuticals and Sanofi, targets the checkpoint inhibitor programmed cell death protein-1 (PD-1). The drug was previously granted Breakthrough Therapy status by the FDA in September 2017.

The Biologics License Application submission to the FDA is based on data from the phase 2, single-arm, open-label EMPOWER-CSCC 1 clinical trial in patients with advanced cutaneous SCC, as well as phase 1 data from two cutaneous SCC expanded cohorts.

No safety and efficacy data are available for cemiplimab at this time.

Find the full press release on the Regeneron website.

[email protected]