The FDA has issued a complete response letter to Sesen Bio, denying the approval of the Biologics License Application for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer.
Similarly, Is Vicinium approved?
The FDA accepted the Sesen Bio’s application for Vicineum in February 2021, and the application was granted priority review. Non-muscle invasive bladder cancer is, as the name suggests, bladder cancer that occurs in the surface of the bladder cancer (the inside surface), not the muscle tissue of the organ.
What is Vicinium? Vicinium is a single protein drug consisting of an Epithelial Cell Adhesion Molecule (EpCAM)-specific antibody fragment fused to a potent pseudomonas toxin. After intravesical instillation, Vicinium binds EpCAM, is internalized and kills tumor cells by inhibiting protein synthesis.
Thereof, What is Vicineum?
Vicineum is a targeted fusion protein designed to overcome the fundamental efficacy and safety challenges inherent in existing antibody-drug conjugates. bringing new hope for treating bladder cancer.
What is Adstiladrin?
Adstiladrin is given by catheter directly into the bladder. It consists of a type of virus that is able to introduce a gene into cells of the bladder. This gene then stimulates the cells of the bladder to produce high quantities of a protein that the body uses to fight cancer.
What is FDA complete response letter?
A complete response letter reflects FDA’s complete review of the data submitted in an original application or abbreviated application (or, where appropriate, a resubmission) and any amendments that the agency has reviewed. The complete response letter will identify any amendments that the agency has not yet reviewed.
How is Vicinium administered?
Induction – 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks. Maintenance – 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Is sesen bio a real company?
At Sesen Bio, we are committed to saving and improving the lives of patients with cancer. We are a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.
What is China Ind?
Historically, the review and approval of a Chinese investigational new drug (IND) has taken a year or even longer to complete, and new drug application (NDA) approval for a new drug lagged behind Western countries by four or five years.
How is Vicineum administered?
Vicineum is administered in a 12 week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week.
What does BCG treat?
Bacillus Calmette-Guerin or BCG is the most common intravesical immunotherapy for treating early-stage bladder cancer. It’s used to help keep the cancer from growing and to help keep it from coming back. BCG is a germ that’s related to the one that causes tuberculosis (TB), but it doesn’t usually cause serious disease.
What is FDA CLR?
A complete response letter (CRL) from the FDA delays a product’s entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them.
Are FDA CRLs public?
CRLs are rarely made public by the product sponsors who receive them. They generally contain proprietary information and are considered trade-secret confidential regulatory correspondence by the FDA.
How long does FDA resubmission take?
D. Although the performance goals for acting on Class 1 resubmissions provide for a gradual yearly decrease in time for review, the FDA will complete review and act upon as many Class 1 resubmissions in two months or less as resources permit.
Who owns sesen bio?
Major institutions are defined as firms or individuals that exercise investment discretion, over the assets of others, in excess of $100 Million.
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New and Sold Out Positions.
| OWNER NAME | SUSQUEHANNA INTERNATIONAL GROUP, LLP |
|---|---|
| SHARES HELD | 642,553 |
| CHANGE (SHARES) | -53,619 |
| CHANGE (%) | -7.702% |
| VALUE (IN 1,000S) | $366 |
Is there an FDA in China?
Established in November 2008, the Office of Global Policy and Strategy’s (OGPS) China Office serves as the lead for the FDA’s on-site presence in China.
Does China have an FDA equivalent?
The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). The predecessor to the NMPA was initially founded in 1998 to oversee drugs and medical devices.
How are drugs approved in China?
National Medical Products Administration
The drug category in which an applicant chooses to register determines the clinical trial application review and approval or filing process. Per the SC-IRP, the SAMR-Org, and CHN-21, China established the State Administration for Market Regulation (SAMR).
Is BCG better than chemo?
BCG is most commonly used in intravesical immunotherapy for NMIBC and appears to be more effective than intravesical chemotherapy in preventing tumor recurrence and progression. Especially for those with high-risk NMIBC, BCG immunotherapy is considered as a gold-standard treatment (29).
Is BCG available now?
A. Merck is the sole maker and supplier of BCG to the United States. While the FDA is exploring opportunities to approve additional strains and supplies of BCG, Merck is still the only approved supplier at this time. There are companies in Japan, Canada, and Europe working to develop their own strains of BCG.
How successful is BCG treatment?
A recent study was published evaluating maintenance BCG therapy [23]. The authors observed a three-year recurrence free survival of 75.3% and disease-free survival of 96.1%. However, they reported a high complication rate of 81.5%.
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