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Paclitaxel based chemotherapy
Paclitaxel based chemotherapy is a Taxane Small molecule drug developed by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. It is currently in Phase 3 development for Adjuvant treatment of node-positive breast cancer, Adjuvant treatment of ovarian cancer, Adjuvant treatment of non-small cell lung cancer.
Paclitaxel works by inhibiting cell division, thereby preventing cancer cells from multiplying and spreading.
Paclitaxel works by inhibiting cell division, thereby preventing cancer cells from multiplying and spreading. Used for Adjuvant treatment of node-positive breast cancer, Adjuvant treatment of ovarian cancer, Adjuvant treatment of non-small cell lung cancer.
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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.
| 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 | Paclitaxel based chemotherapy |
|---|---|
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Drug class | Taxane |
| Target | Microtubules |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Paclitaxel binds to tubulin, a protein that makes up microtubules, and prevents them from disassembling. This leads to the accumulation of stable microtubules, which in turn prevents the cell from entering the mitotic phase of cell division. As a result, cancer cells are unable to multiply and spread.
Approved indications
- Adjuvant treatment of node-positive breast cancer
- Adjuvant treatment of ovarian cancer
- Adjuvant treatment of non-small cell lung cancer
- Treatment of AIDS-related Kaposi's sarcoma
- Treatment of breast cancer
- Treatment of non-small cell lung cancer
- Treatment of ovarian cancer
- Treatment of pancreatic cancer
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Fatigue
- Nausea
- Vomiting
- Diarrhea
- Constipation
Key clinical trials
- BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia (PHASE1)
- Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (PHASE2)
- A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) (PHASE1, PHASE2)
- Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma (PHASE1, PHASE2)
- 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)
- Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO]) (PHASE3)
- Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC) (PHASE1, PHASE2)
- Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) (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:
- Paclitaxel based chemotherapy CI brief — competitive landscape report
- Paclitaxel based chemotherapy updates RSS · CI watch RSS
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences portfolio CI
Frequently asked questions about Paclitaxel based chemotherapy
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Related
- Drug class: All Taxane drugs
- Target: All drugs targeting Microtubules
- Manufacturer: Cancer Institute and Hospital, Chinese Academy of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Adjuvant treatment of node-positive breast cancer
- Indication: Drugs for Adjuvant treatment of ovarian cancer
- Indication: Drugs for Adjuvant treatment of non-small cell lung cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing