Last reviewed 2026-05-19 · How we verify

Bendamustine, Rituximab, Lenalidomide

German CLL Study Group · Phase 1 active Small molecule ✓ Verified May 2026

Bendamustine, Rituximab, Lenalidomide is a Small molecule drug developed by German CLL Study Group. It is currently in Phase 1 development. Also known as: Ribomustine, MabThera, Revlimid.

Bendamustine, Rituximab, and Lenalidomide are medications used to treat various conditions, including Relapsed Follicular Lymphoma, Refractory Follicular Lymphoma, Lymphoma, Non-Hodgkin, and Chronic Lymphocytic Leukemia. Rituximab is an antibody that binds to the B-lymphocyte antigen CD20, while the mechanism of Bendamustine and Lenalidomide is not specified in the provided facts.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Bendamustine, Rituximab, Lenalidomide
Also known as	Ribomustine, MabThera, Revlimid
Sponsor	German CLL Study Group
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

Bendamustine, Rituximab, Lenalidomide CI brief — competitive landscape report
Bendamustine, Rituximab, Lenalidomide updates RSS · CI watch RSS
German CLL Study Group portfolio CI

Frequently asked questions about Bendamustine, Rituximab, Lenalidomide

What is Bendamustine, Rituximab, Lenalidomide?

Bendamustine, Rituximab, Lenalidomide is a Small molecule drug developed by German CLL Study Group.

Who makes Bendamustine, Rituximab, Lenalidomide?

Bendamustine, Rituximab, Lenalidomide is developed by German CLL Study Group (see full German CLL Study Group pipeline at /company/german-cll-study-group).

Is Bendamustine, Rituximab, Lenalidomide also known as anything else?

Bendamustine, Rituximab, Lenalidomide is also known as Ribomustine, MabThera, Revlimid.

What development phase is Bendamustine, Rituximab, Lenalidomide in?

Bendamustine, Rituximab, Lenalidomide is in Phase 1.

Manufacturer: German CLL Study Group — full pipeline
Also known as: Ribomustine, MabThera, Revlimid

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