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First-Line Chemotherapy Agents
First-Line Chemotherapy Agents is a Small molecule drug developed by Genentech, Inc.. It is currently in Phase 2 development.
Albumin-bound Paclitaxel is used as a first-line chemotherapy agent in the treatment of Triple-negative Breast Cancer, Gastric Cancer, Non-Small Cell Lung Cancer, Esophageal Neoplasm Metastatic, and Esophageal Cancer Stage IVb. Additionally, Apatinib Mesylate and Bevacizumab are also used as first-line chemotherapy agents in these conditions, with Apatinib Mesylate targeting angiogenesis and Bevacizumab targeting angiogenesis as well.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | First-Line Chemotherapy Agents |
|---|---|
| Sponsor | Genentech, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Dyspnea
- Fatigue
- Cough
- Anorexia
- Weight loss
- Glucose, serum-high (hyperglycemia)
- Dizziness
- Esophagitis
- Nausea
- Hemoglobin - Low
- Pain - Extremity-limb
- Neuropathy: sensory
Key clinical trials
- Study of LYL314 in Aggressive Large B-Cell Lymphoma (PHASE1, PHASE2)
- A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer (PHASE3)
- A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (PHASE1, PHASE2)
- Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (PHASE2, PHASE3)
- Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) (PHASE1, PHASE2)
- Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment (PHASE2)
- Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma (PHASE2)
- Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL) (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:
- First-Line Chemotherapy Agents CI brief — competitive landscape report
- First-Line Chemotherapy Agents updates RSS · CI watch RSS
- Genentech, Inc. portfolio CI
Frequently asked questions about First-Line Chemotherapy Agents
What is First-Line Chemotherapy Agents?
Who makes First-Line Chemotherapy Agents?
What development phase is First-Line Chemotherapy Agents in?
What are the side effects of First-Line Chemotherapy Agents?
Related
- Manufacturer: Genentech, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing