Last reviewed 2026-05-27 · How we verify

R-mNHL-BFM-90

National Research Center for Hematology, Russia · Phase 3 active Small molecule Under review

R-mNHL-BFM-90 is a Chemotherapy regimen Small molecule drug developed by National Research Center for Hematology, Russia. It is currently in Phase 3 development for Non-Hodgkin lymphoma, particularly in children and young adults.

R-mNHL-BFM-90 is a chemotherapy regimen used to treat certain types of non-Hodgkin lymphoma.

The R-mNHL-BFM-90 is a treatment program for Diffuse Large B-Cell Lymphoma. It is a small molecule modality, as classified by ChEMBL.

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	R-mNHL-BFM-90
Sponsor	National Research Center for Hematology, Russia
Drug class	Chemotherapy regimen
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

The regimen involves a combination of chemotherapy drugs, including methotrexate, cytarabine, and dexamethasone, which work together to kill cancer cells. The exact mechanism of action is not fully understood, but it is thought to involve the inhibition of DNA synthesis and cell division.

Approved indications

Non-Hodgkin lymphoma, particularly in children and young adults

Common side effects

Nausea and vomiting
Fatigue
Hair loss
Infection
Anemia

Key clinical trials

R-Dose-adjusted (DA) - EPOCH-21 Versus R-modified Non-Hodgkin Lymphoma (NHL)-Berlin-Frankfurt-Munster (BFM)-90 Program (mNHL-BFM-90) and Autologous Stem Cells Transplantation (Auto-SCT) in DLBCL With Poor Prognosis (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:

R-mNHL-BFM-90 CI brief — competitive landscape report
R-mNHL-BFM-90 updates RSS · CI watch RSS
National Research Center for Hematology, Russia portfolio CI

Frequently asked questions about R-mNHL-BFM-90

What is R-mNHL-BFM-90?

R-mNHL-BFM-90 is a Chemotherapy regimen drug developed by National Research Center for Hematology, Russia, indicated for Non-Hodgkin lymphoma, particularly in children and young adults.

How does R-mNHL-BFM-90 work?

R-mNHL-BFM-90 is a chemotherapy regimen used to treat certain types of non-Hodgkin lymphoma.

What is R-mNHL-BFM-90 used for?

R-mNHL-BFM-90 is indicated for Non-Hodgkin lymphoma, particularly in children and young adults.

Who makes R-mNHL-BFM-90?

R-mNHL-BFM-90 is developed by National Research Center for Hematology, Russia (see full National Research Center for Hematology, Russia pipeline at /company/national-research-center-for-hematology-russia).

What drug class is R-mNHL-BFM-90 in?

R-mNHL-BFM-90 belongs to the Chemotherapy regimen class. See all Chemotherapy regimen drugs at /class/chemotherapy-regimen.

What development phase is R-mNHL-BFM-90 in?

R-mNHL-BFM-90 is in Phase 3.

What are the side effects of R-mNHL-BFM-90?

Common side effects of R-mNHL-BFM-90 include Nausea and vomiting, Fatigue, Hair loss, Infection, Anemia.

Drug class: All Chemotherapy regimen drugs
Manufacturer: National Research Center for Hematology, Russia — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-Hodgkin lymphoma, particularly in children and young adults

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