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Pemetrexed + cisplatin
Pemetrexed + cisplatin is a Antifolate antimetabolite + platinum-based alkylating agent Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Metastatic non-small cell lung cancer (nonsquamous histology), Malignant pleural mesothelioma, Advanced gastric cancer. Also known as: Platinum based Standard of Care Chemotherapy.
Pemetrexed inhibits multiple folate-dependent enzymes involved in nucleotide synthesis, while cisplatin causes DNA crosslinking; together they disrupt cancer cell division and DNA replication.
Pemetrexed is used to treat various types of cancer, including non-small cell lung cancer (NSCLC), as per ClinicalTrials.gov. Pemetrexed is often combined with cisplatin for the treatment of NSCLC, although the specific combination is not mentioned in the provided facts, it is a well-documented combination in clinical practice.
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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.
| 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 | Pemetrexed + cisplatin |
|---|---|
| Also known as | Platinum based Standard of Care Chemotherapy |
| Sponsor | AstraZeneca |
| Drug class | Antifolate antimetabolite + platinum-based alkylating agent |
| Target | Thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase (pemetrexed); DNA (cisplatin) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pemetrexed is a multitargeted antifolate that inhibits thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase, blocking pyrimidine and purine synthesis. Cisplatin is a platinum-based alkylating agent that forms DNA adducts and crosslinks, preventing DNA replication and transcription. The combination provides synergistic cytotoxic activity against rapidly dividing cancer cells.
Approved indications
- Metastatic non-small cell lung cancer (nonsquamous histology)
- Malignant pleural mesothelioma
- Advanced gastric cancer
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Nausea/vomiting
- Nephrotoxicity
- Peripheral neuropathy
- Mucositis
- Fatigue
Key clinical trials
- Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer (PHASE2)
- Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin (PHASE1, PHASE2)
- A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18) (PHASE1)
- Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma (PHASE1, PHASE2)
- A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors (PHASE1)
- A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC (PHASE3)
- Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer (PHASE3)
- A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (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:
- Pemetrexed + cisplatin CI brief — competitive landscape report
- Pemetrexed + cisplatin updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Pemetrexed + cisplatin
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Related
- Drug class: All Antifolate antimetabolite + platinum-based alkylating agent drugs
- Target: All drugs targeting Thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase (pemetrexed); DNA (cisplatin)
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic non-small cell lung cancer (nonsquamous histology)
- Indication: Drugs for Malignant pleural mesothelioma
- Indication: Drugs for Advanced gastric cancer
- Also known as: Platinum based Standard of Care Chemotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing