Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab

German CLL Study Group · Phase 2 active Small molecule

Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab is a Small molecule drug developed by German CLL Study Group. It is currently in Phase 2 development. Also known as: Mabcampath, Fludarabine, Endoxan, Novantron.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab
Also known as	Mabcampath, Fludarabine, Endoxan, Novantron
Sponsor	German CLL Study Group
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Combined Immunochemotherapy in Patients With T-Prolymphocytic Leukemia (T-PLL) (PHASE2)
• Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia (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:

• Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab CI brief — competitive landscape report
• Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab updates RSS · CI watch RSS
• German CLL Study Group portfolio CI

Frequently asked questions about Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab

What is Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab?

Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab is a Small molecule drug developed by German CLL Study Group.

Who makes Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab?

Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab is developed by German CLL Study Group (see full German CLL Study Group pipeline at /company/german-cll-study-group).

Is Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab also known as anything else?

Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab is also known as Mabcampath, Fludarabine, Endoxan, Novantron.

What development phase is Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab in?

Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab is in Phase 2.

Related

• Manufacturer: German CLL Study Group — full pipeline
• Also known as: Mabcampath, Fludarabine, Endoxan, Novantron