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Gemcitabine + cisplatin

AstraZeneca · Phase 3 active Small molecule

Gemcitabine + cisplatin is a Chemotherapy combination (nucleoside analog + platinum alkylating agent) Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Metastatic or locally advanced non-small cell lung cancer, Metastatic pancreatic cancer, Urothelial carcinoma. Also known as: Background Gemcitabine-based Chemotherapy Regimen, Gemzar, Platinum based Standard of Care Chemotherapy, GC.

Gemcitabine and cisplatin work synergistically as chemotherapy agents that damage DNA and inhibit cell replication, leading to cancer cell death.

Gemcitabine and cisplatin work synergistically as chemotherapy agents that damage DNA and inhibit cell replication, leading to cancer cell death. Used for Metastatic or locally advanced non-small cell lung cancer, Metastatic pancreatic cancer, Urothelial carcinoma.

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
    AstraZeneca 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 nameGemcitabine + cisplatin
Also known asBackground Gemcitabine-based Chemotherapy Regimen, Gemzar, Platinum based Standard of Care Chemotherapy, GC, GemCis
SponsorAstraZeneca
Drug classChemotherapy combination (nucleoside analog + platinum alkylating agent)
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, causing chain termination and apoptosis. Cisplatin is a platinum-based alkylating agent that forms DNA cross-links, preventing replication and transcription. Together, they provide complementary cytotoxic mechanisms that enhance overall anti-tumor activity.

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 Gemcitabine + cisplatin

What is Gemcitabine + cisplatin?

Gemcitabine + cisplatin is a Chemotherapy combination (nucleoside analog + platinum alkylating agent) drug developed by AstraZeneca, indicated for Metastatic or locally advanced non-small cell lung cancer, Metastatic pancreatic cancer, Urothelial carcinoma.

How does Gemcitabine + cisplatin work?

Gemcitabine and cisplatin work synergistically as chemotherapy agents that damage DNA and inhibit cell replication, leading to cancer cell death.

What is Gemcitabine + cisplatin used for?

Gemcitabine + cisplatin is indicated for Metastatic or locally advanced non-small cell lung cancer, Metastatic pancreatic cancer, Urothelial carcinoma, Ovarian cancer.

Who makes Gemcitabine + cisplatin?

Gemcitabine + cisplatin is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

Is Gemcitabine + cisplatin also known as anything else?

Gemcitabine + cisplatin is also known as Background Gemcitabine-based Chemotherapy Regimen, Gemzar, Platinum based Standard of Care Chemotherapy, GC, GemCis.

What drug class is Gemcitabine + cisplatin in?

Gemcitabine + cisplatin belongs to the Chemotherapy combination (nucleoside analog + platinum alkylating agent) class. See all Chemotherapy combination (nucleoside analog + platinum alkylating agent) drugs at /class/chemotherapy-combination-nucleoside-analog-platinum-alkylating-agent.

What development phase is Gemcitabine + cisplatin in?

Gemcitabine + cisplatin is in Phase 3.

What are the side effects of Gemcitabine + cisplatin?

Common side effects of Gemcitabine + cisplatin include Myelosuppression (neutropenia, thrombocytopenia, anemia), Nausea and vomiting, Fatigue, Nephrotoxicity, Neurotoxicity (peripheral neuropathy), Alopecia.

Related

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