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

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

Shots:

  • The US FDA has accepted BLA filing for cosibelimab in patients with metastatic cSCC or LA cSCC who are not candidates for curative surgery or radiation. The US FDA’s decision is expected on January 3, 2024
  • The submission was based on the registration-enabling clinical trial evaluating cosibelimab. The trial met its 1EPs i.e., the therapy showed a confirmed ORR of 47.4% based on an independent central review in the metastatic cSCC cohort. The results were presented at the ASCO 2022
  • In the interim results from the LA cSCC cohort, ORR (54.8%) based on independent central review. Cosibelimab is a high affinity, fully-human mAb of IgG1 subtype that binds to PD-L1 & blocks the PD-L1 interaction with the PD-1 and B7.1 receptors

Ref: Checkpoint  | Image: Checkpoint 

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

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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