This section highlights FDA-related milestones and regulatory updates for drugs developed by Checkpoint Therapeutics (CKPT).
Over the past two years, Checkpoint Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Cosibelimab and Cosibelimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Cosibelimab (cSCC) FDA Regulatory Timeline and Events
Cosibelimab (cSCC) is a drug developed by Checkpoint Therapeutics for the following indication: Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cosibelimab (cSCC)
- Announced Date:
- December 13, 2024
- Indication:
- Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
Announcement
Checkpoint Therapeutics announced that the U.S. Food and Drug Administration ("FDA") has approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma ("cSCC") or locally advanced cSCC who are not candidates for curative surgery or curative radiation.
AI Summary
Checkpoint Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved UNLOXCYT™ (cosibelimab-ipdl) for adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or radiation. This approval marks a significant milestone as UNLOXCYT is the first PD-L1 blocking antibody approved for this indication. The treatment is designed for patients facing advanced cases of one of the most common skin cancers, offering a new immunotherapy option intended to boost the body’s natural anti-tumor response by blocking PD-L1. UNLOXCYT is administered at a dosage of 1,200 mg through an intravenous infusion over 60 minutes every three weeks, providing a new hope for patients with limited treatment options.
Read Announcement- Drug:
- Cosibelimab (cSCC)
- Announced Date:
- July 25, 2024
- Estimated Event Date Range:
- December 28, 2024 - December 28, 2024
- Target Action Date:
- December 28, 2024
- Indication:
- Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
Announcement
Checkpoint Therapeutics, announced that the FDA has set a Prescription Drug User Fee Act ("PDUFA") goal date of December 28, 2024.
AI Summary
Checkpoint Therapeutics announced that the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024, for its resubmission of the Biologics License Application (BLA) for cosibelimab. This date marks when the FDA plans to complete its review of the application for cosibelimab, an anti-PD-L1 antibody aimed at treating adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation.
The resubmission addresses earlier inspection findings related to the company’s third-party manufacturing partner. Checkpoint looks forward to working closely with the FDA to finalize the review process, with hope that cosibelimab’s unique dual mechanism of action will offer a promising new treatment option for patients suffering from this form of cancer.
Read Announcement- Drug:
- Cosibelimab (cSCC)
- Announced Date:
- July 25, 2024
- Indication:
- Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
Announcement
Checkpoint Therapeutics, announced that the U.S. Food and Drug Administration ("FDA") has accepted for review Checkpoint's resubmission of its Biologics License Application ("BLA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation.
AI Summary
Checkpoint Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmission of the Biologics License Application (BLA) for cosibelimab. Cosibelimab is an anti-PD-L1 antibody, which is being developed as a potential new treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation.
The FDA’s acceptance of the resubmission means that the agency is now set to review the application, with a goal date under the Prescription Drug User Fee Act (PDUFA) of December 28, 2024. This step follows previous discussions with the FDA, and Checkpoint looks forward to finalizing the review process to offer a new treatment option to patients suffering from cSCC.
Read Announcement- Drug:
- Cosibelimab (cSCC)
- Announced Date:
- July 15, 2024
- Indication:
- Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
Announcement
Checkpoint Therapeutics and GC Cell announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody with dual mechanism of action, with GC Cell's Immuncell-LC, an innovative autologous Cytokine Induced Killer ("CIK") T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells.
AI Summary
Checkpoint Therapeutics and GC Cell have announced a collaboration to explore the potential benefits of combining their innovative immunotherapies. The partnership will investigate cosibelimab, Checkpoint’s anti-PD-L1 antibody with a dual mechanism of action, alongside GC Cell’s Immuncell-LC, an autologous Cytokine Induced Killer (CIK) T cell therapy featuring both cytotoxic T lymphocytes and natural killer T cells. The initial studies will be conducted in vitro to determine if this combination can enhance the immune system's ability to target and destroy cancer cells. Researchers believe that cosibelimab’s ability to block PD-L1 and trigger antibody-dependent cellular cytotoxicity, when paired with the powerful T cell response from Immuncell-LC, could lead to more effective cancer treatment strategies. Positive results from these studies may pave the way for future in vivo research and clinical trials in immuno-oncology.
Read Announcement- Drug:
- Cosibelimab (cSCC)
- Announced Date:
- July 2, 2024
- Indication:
- Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
Announcement
Checkpoint Therapeutics announced it has completed the resubmission of its Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation.,
AI Summary
Checkpoint Therapeutics has completed the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for cosibelimab. This anti-PD-L1 antibody is being developed as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who cannot undergo curative surgery or radiation. The resubmission follows a recent alignment with the FDA on addressing manufacturing issues noted in a previous complete response letter, with the agency having raised concerns only related to the multi-sponsor inspection of the company’s third-party contract manufacturing organization.
The application is supported by promising data from studies in advanced cSCC, showing encouraging safety and efficacy results. The FDA resubmission strategy aims to resolve all noted deficiencies and move closer to a potential marketing approval for cosibelimab, offering a new option for patients with difficult-to-treat cSCC.
Read Announcement- Drug:
- Cosibelimab (cSCC)
- Announced Date:
- June 24, 2024
- Indication:
- Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
Announcement
Checkpoint Therapeutics, announced it has reached alignment with the Food and Drug Administration ("FDA") on its biologics license application ("BLA") resubmission strategy for cosibelimab. Accordingly, Checkpoint plans to move forward with a mid-year BLA resubmission seeking the U.S. marketing approval for cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation.
AI Summary
Checkpoint Therapeutics announced that it has reached agreement with the FDA on its strategy for resubmitting the biologics license application (BLA) for cosibelimab. The company plans to move forward with a mid-year resubmission in the United States, aiming to secure marketing approval for cosibelimab. This potential treatment is intended for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are unable to undergo curative surgery or radiation.
The alignment with the FDA focuses on addressing the specific manufacturing issues previously identified. By refining its resubmission approach, Checkpoint hopes to overcome the deficiencies noted in earlier reviews. This step is an important move toward providing a new immunotherapy option for patients with advanced cSCC, ultimately offering an alternative treatment pathway where standard curative options are not viable.
Read Announcement
Cosibelimab (formerly CK-301) FDA Regulatory Events
Cosibelimab (formerly CK-301) is a drug developed by Checkpoint Therapeutics for the following indication: Metastatic cutaneous squamous cell carcinoma (mCSCC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cosibelimab (formerly CK-301)
- Announced Date:
- September 16, 2024
- Indication:
- Metastatic cutaneous squamous cell carcinoma (mCSCC)
Announcement
Checkpoint Therapeutics announced the presentation of longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma ("cSCC") during the European Society for Medical Oncology ("ESMO") Congress 2024, which is taking place in Barcelona, Spain, from September 13 to 17, 2024.
AI Summary
Checkpoint Therapeutics has announced new longer-term data for cosibelimab, its anti-PD-L1 antibody, in treating patients with locally advanced and metastatic cutaneous squamous cell carcinoma (cSCC). The data were presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from September 13 to 17, 2024. Results from the pivotal trial showed a deepening of response over time, with higher objective response rates and increased complete response rates compared to the initial analysis. Involving 109 patients with advanced cSCC, the study highlighted that extended follow-up led to meaningful improvements in response durability, with median follow-up durations reaching 24.1 and 29.3 months in locally advanced and metastatic cases, respectively. The findings reinforce the potential of cosibelimab as a promising immunotherapy option for advanced cSCC with a sustained safety profile.
Read Announcement
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