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Checkpoint Therapeutics’ Unloxcyt (Cosibelimab-ipdl) Receives the US FDA’s Approval for Cutaneous Squamous Cell Carcinoma (cSCC)

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Checkpoint Therapeutics

Checkpoint Therapeutics’ Unloxcyt (Cosibelimab-ipdl) Receives the US FDA’s Approval for Cutaneous Squamous Cell Carcinoma (cSCC)

Shots:   

  • Checkpoint has received the US FDA’s approval for Unloxcyt (1,200mg, IV, over 60 minutes, Q3W) to treat metastatic or locally advanced cSCC in adults, ineligible for curative surgery or radiation 

  • Approval was based on the P-I (CK-301-101) trial in solid tumor patients (incl. cSCC: N=109), showing ORR of 48% with mDoR of 17.7mos. in locally advanced cSCC patients (n=31) & ORR of 47% with mDoR not achieved in metastatic disease patients (n=78) 

  • Unloxcyt is a human, anti-PD-L1 IgG1 mAb which blocks the interaction between PD-L1 & T cell receptors (PD-1 & B7.1) producing an anti-tumor immune response 

Ref: Checkpoint | Image: Checkpoint 

Related News:- Checkpoint Reports the US FDA Acceptance of BLA for Cosibelimab to Treat Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

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Dipanshu Dixit

A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com

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