Vicinium

Sesen Bio, Inc. · Phase 3 active Biologic

Vicinium is a Biologic drug developed by Sesen Bio, Inc.. It is currently in Phase 3 development. Also known as: VB4-845, Oportuzumab monatox.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• Baseline phase 3 → approval rate +58.3pp
  Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Vicinium
Also known as	VB4-845, Oportuzumab monatox
Sponsor	Sesen Bio, Inc.
Modality	Biologic
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG (PHASE3)
• Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer (PHASE3)
• Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Vicinium CI brief — competitive landscape report
• Vicinium updates RSS · CI watch RSS
• Sesen Bio, Inc. portfolio CI

Frequently asked questions about Vicinium

What is Vicinium?

Vicinium is a Biologic drug developed by Sesen Bio, Inc..

Who makes Vicinium?

Vicinium is developed by Sesen Bio, Inc. (see full Sesen Bio, Inc. pipeline at /company/sesen-bio-inc).

Is Vicinium also known as anything else?

Vicinium is also known as VB4-845, Oportuzumab monatox.

What development phase is Vicinium in?

Vicinium is in Phase 3.

Related

• Manufacturer: Sesen Bio, Inc. — full pipeline
• Therapeutic area: All drugs in Other
• Also known as: VB4-845, Oportuzumab monatox