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Oxaliplatin Based Chemotherapy

Amgen · Phase 3 active Small molecule Under review Quality 0/100

Oxaliplatin Based Chemotherapy is a Platinum-based chemotherapy agent Small molecule drug developed by Amgen. It is currently in Phase 3 development for Metastatic colorectal cancer (in combination with fluorouracil and leucovorin), Adjuvant treatment of stage III colon cancer (in combination with fluorouracil and leucovorin), Advanced ovarian cancer. Also known as: FOLFOX 4, FOLFOX 5, Modified FOLFOX 6, FOLFOX 7.

Oxaliplatin is a platinum-based chemotherapy agent that forms DNA crosslinks to kill rapidly dividing cancer cells.

Oxaliplatin is a small molecule DNA inhibitor used in chemotherapy, classified as an inhibitor. It is studied for various conditions, including Advanced Breast Cancer, Metastatic Breast Cancer, Colorectal Cancer, and Metastatic Colorectal Adenocarcinoma, among others.

Likelihood of approval
64.3% 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.
  • Big-pharma sponsor +3.0pp
    Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
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 nameOxaliplatin Based Chemotherapy
Also known asFOLFOX 4, FOLFOX 5, Modified FOLFOX 6, FOLFOX 7, Oxaliplatin
SponsorAmgen
Drug classPlatinum-based chemotherapy agent
TargetDNA
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

Oxaliplatin is a third-generation platinum compound that binds to DNA and forms interstrand and intrastrand crosslinks, preventing DNA replication and transcription in cancer cells. This leads to cell cycle arrest and apoptosis. Unlike earlier platinum agents, oxaliplatin has a unique diaminocyclohexane carrier ligand that may confer different toxicity and efficacy profiles.

Approved indications

Common side effects

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Oxaliplatin Based Chemotherapy

What is Oxaliplatin Based Chemotherapy?

Oxaliplatin Based Chemotherapy is a Platinum-based chemotherapy agent drug developed by Amgen, indicated for Metastatic colorectal cancer (in combination with fluorouracil and leucovorin), Adjuvant treatment of stage III colon cancer (in combination with fluorouracil and leucovorin), Advanced ovarian cancer.

How does Oxaliplatin Based Chemotherapy work?

Oxaliplatin is a platinum-based chemotherapy agent that forms DNA crosslinks to kill rapidly dividing cancer cells.

What is Oxaliplatin Based Chemotherapy used for?

Oxaliplatin Based Chemotherapy is indicated for Metastatic colorectal cancer (in combination with fluorouracil and leucovorin), Adjuvant treatment of stage III colon cancer (in combination with fluorouracil and leucovorin), Advanced ovarian cancer, Non-small cell lung cancer.

Who makes Oxaliplatin Based Chemotherapy?

Oxaliplatin Based Chemotherapy is developed by Amgen (see full Amgen pipeline at /company/amgen).

Is Oxaliplatin Based Chemotherapy also known as anything else?

Oxaliplatin Based Chemotherapy is also known as FOLFOX 4, FOLFOX 5, Modified FOLFOX 6, FOLFOX 7, Oxaliplatin.

What drug class is Oxaliplatin Based Chemotherapy in?

Oxaliplatin Based Chemotherapy belongs to the Platinum-based chemotherapy agent class. See all Platinum-based chemotherapy agent drugs at /class/platinum-based-chemotherapy-agent.

What development phase is Oxaliplatin Based Chemotherapy in?

Oxaliplatin Based Chemotherapy is in Phase 3.

What are the side effects of Oxaliplatin Based Chemotherapy?

Common side effects of Oxaliplatin Based Chemotherapy include Peripheral neuropathy, Nausea and vomiting, Diarrhea, Neutropenia, Anemia, Thrombocytopenia.

What does Oxaliplatin Based Chemotherapy target?

Oxaliplatin Based Chemotherapy targets DNA and is a Platinum-based chemotherapy agent.

Related

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