Amid ethical claims, Sesen withdraws bladder cancer drug application from Europe

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Less than 10 days after the United States Food and Drug Administration (FDA) criticized bladder cancer drug Sesen Bios with a full response letter, the company withdrew its marketing authorization for the ‘European Union.

In a filing with the U.S. Securities and Exchange Commission, Sesen Bio said his decision to withdraw the MAA was based on the FDA’s CRL. The company has acknowledged that certain components of the European Medicines Agency’s review are linked to some of the elements that prompted the FDA to release the CRL for Viceneum (oportuzumab monatox-qqrs) as a treatment for bladder cancer. non invasive ). Sesen is putting plans for further approval in Europe on hold until the FDA clarifies the next steps to get approval.

The company has also requested a Type A meeting with the FDA to discuss these necessary steps. Additionally, Sesen made a curious comment indicating that he is committed to the highest standards of ethics and integrity and continues to believe in the safety and efficacy data of Vicineum.

This comment refers to a STAT News report alleging that Sesens’ entire clinical program for Viceneum was marked by multiple instances of unethical behavior. According to the report, the company’s clinical program saw thousands of study rule violations and overwhelming misconduct by investigators. He also added that the drug Sesens had much poorer safety data than reported.

The news also revealed that the company had not revealed any worrying signs of toxicity and was supported by hundreds of pages of internal Sesen documents, as well as confirmation from three people familiar with the matter. Sesen has yet to comment on the allegations raised by the report.

Vicenium, the drug Sesen hopes to gain approval for, is a recombinant fusion protein. Vicenium targets epithelial cell adhesion molecule (EpCAM) antigens located on the surface of tumor cells. It aims to deliver what has been described as a potent Pseudomonas Exotoxin A protein payload to the tumor.

When the FDA rejected Vicenium, the regulatory agency recommended that Sesen perform additional clinical and statistical data analysis. The FDA also recommended addressing issues related to the company’s chemistry, manufacturing, and controls (CMC). In the CRL, the FDA expressed concerns regarding the manufacturing of drugs and drug products, cell banking, characterization, reuse of resins, reference standards, methods, specifications, stability and microbiology. .

Shares of Sesen Bio were down nearly 2% in pre-market trading to $ 1.05, losing gains on Wednesday. Since CRL’s issuance, Sesens stock has fallen from a high of $ 4.91 per share in 2021.

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