Checkpoint Therapeutics Faces FDA Setback, but Optimism Persists for Skin Cancer Therapy

Checkpoint Therapeutics, headquartered in Waltham, Massachusetts, recently encountered a significant setback as the U.S. Food and Drug Administration (FDA) declined to approve its experimental therapy aimed at treating cutaneous squamous cell carcinoma (CSCC); a form of skin cancer.

 This regulatory decision came following an inspection at a contract manufacturer, prompting a steep decline of 47.3% in Checkpoint’s shares to $1.7 in premarket trade. This downturn positioned the company among the poorest-performing stocks across various U.S. stock exchanges.

The therapy in question, cosibelimab, represents Checkpoint’s lead development candidate, and the marketing application was submitted earlier this year. Despite the setback, the FDA’s complete response letter did not raise any concerns regarding the therapy’s safety or the integrity of the data provided by the company.

Cosibelimab exhibits potential in tackling cutaneous squamous cell carcinoma, which ranks as one of the most common forms of skin cancer in the United States, boasting an annual report of around 1 million cases. The trial data presented by Checkpoint demonstrated a noteworthy 47.4% reduction or clearance of cancerous tumors. It should be noted, however,  that the FDA’s determination was associated with discoveries stemming from a comprehensive evaluation by multiple sponsors of Checkpoint’s external contract manufacturer, rather than particular concerns related to the therapy itself, such as labeling clinical data compilation, or safety.

James Oliviero, the CEO of Checkpoint Therapeutics, remains optimistic about the future prospects of cosibelimab. In response to the FDA’s decision, Oliviero stated, “We believe we can address the feedback in a resubmission to enable marketing approval in 2024.” 

In light of these sentiments, the company has made its commitment to resubmitting the biologic license application for cosibelimab in the future clear.

For those patients suffering from metastatic or locally advanced cutaneous squamous cell carcinoma who are not suitable candidates for radiation or therapy,  Cosibelimab is specifically designed to target their needs. Despite the setback, the therapy addresses a critical medical need, as approximately 40,000 cases of cutaneous squamous cell carcinoma progress to an advanced stage annually, resulting in an estimated 15,000 deaths from the disease.

The challenges encountered by Checkpoint Therapeutics highlight the intricacies of the regulatory landscape in the biopharmaceutical industry. Navigating the FDA’s approval process involves not only demonstrating the efficacy and safety of a therapeutic candidate but also ensuring rigorous adherence to manufacturing standards. The complete response letter, while a setback, serves as a roadmap for Checkpoint to address the identified issues during the multi-sponsor inspection.

The potential approval of this therapy could represent a significant advancement in the treatment of cutaneous squamous cell carcinoma, offering hope to patients facing limited treatment options. 

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