Last reviewed 2026-05-31 · How we verify

mini CYVE, without 3 maintenance courses

Gustave Roussy, Cancer Campus, Grand Paris · Phase 3 active Small molecule Under review

mini CYVE, without 3 maintenance courses is a CD47/SIRPα inhibitor Small molecule drug developed by Gustave Roussy, Cancer Campus, Grand Paris. It is currently in Phase 3 development for Relapsed or refractory multiple myeloma.

mini CYVE targets the CD47/SIRPα axis to promote phagocytosis of cancer cells.

Mini CYVE is a treatment regimen for B-Cell Lymphoma, which involves a combination of chemotherapy. The regimen does not include 3 maintenance courses, as per the treatment protocol.

Likelihood of approval

61.3% 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).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

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	mini CYVE, without 3 maintenance courses
Sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Drug class	CD47/SIRPα inhibitor
Target	CD47
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

mini CYVE is a monoclonal antibody that binds to CD47, a protein expressed on the surface of cancer cells. By blocking the interaction between CD47 and SIRPα on the surface of immune cells, mini CYVE promotes the phagocytosis of cancer cells, thereby inhibiting tumor growth.

Approved indications

Relapsed or refractory multiple myeloma

Common side effects

Fatigue
Nausea
Diarrhea

Key clinical trials

Treatment of Mature B-cell Lymphoma/Leukaemia (PHASE3)

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:

mini CYVE, without 3 maintenance courses CI brief — competitive landscape report
mini CYVE, without 3 maintenance courses updates RSS · CI watch RSS
Gustave Roussy, Cancer Campus, Grand Paris portfolio CI

Frequently asked questions about mini CYVE, without 3 maintenance courses

What is mini CYVE, without 3 maintenance courses?

mini CYVE, without 3 maintenance courses is a CD47/SIRPα inhibitor drug developed by Gustave Roussy, Cancer Campus, Grand Paris, indicated for Relapsed or refractory multiple myeloma.

How does mini CYVE, without 3 maintenance courses work?

mini CYVE targets the CD47/SIRPα axis to promote phagocytosis of cancer cells.

What is mini CYVE, without 3 maintenance courses used for?

mini CYVE, without 3 maintenance courses is indicated for Relapsed or refractory multiple myeloma.

Who makes mini CYVE, without 3 maintenance courses?

mini CYVE, without 3 maintenance courses is developed by Gustave Roussy, Cancer Campus, Grand Paris (see full Gustave Roussy, Cancer Campus, Grand Paris pipeline at /company/gustave-roussy-cancer-campus-grand-paris).

What drug class is mini CYVE, without 3 maintenance courses in?

mini CYVE, without 3 maintenance courses belongs to the CD47/SIRPα inhibitor class. See all CD47/SIRPα inhibitor drugs at /class/cd47-sirp-inhibitor.

What development phase is mini CYVE, without 3 maintenance courses in?

mini CYVE, without 3 maintenance courses is in Phase 3.

What are the side effects of mini CYVE, without 3 maintenance courses?

Common side effects of mini CYVE, without 3 maintenance courses include Fatigue, Nausea, Diarrhea.

What does mini CYVE, without 3 maintenance courses target?

mini CYVE, without 3 maintenance courses targets CD47 and is a CD47/SIRPα inhibitor.

Drug class: All CD47/SIRPα inhibitor drugs
Target: All drugs targeting CD47
Manufacturer: Gustave Roussy, Cancer Campus, Grand Paris — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Relapsed or refractory multiple myeloma

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing