Last reviewed · How we verify
Second-Line Chemotherapy Agents
Second-Line Chemotherapy Agents is a Small molecule drug developed by Genentech, Inc.. It is currently in Phase 2 development.
Second-line chemotherapy agents for various cancers, including Hepatocellular Carcinoma (HCC), Colorectal Cancer Metastatic, Non-Small-Cell Lung Cancer, Gastric Cancer, and Small Cell Lung Cancer, include irinotecan liposome (II) and combinations of TACE/HAIC with Immuno-Targeted Therapy. These agents are studied in clinical trials for their effectiveness in treating cancers that have not responded to first-line therapy.
-
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 | Second-Line Chemotherapy Agents |
|---|---|
| Sponsor | Genentech, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) (PHASE3)
- HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer (NA)
- Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum (NA)
- 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 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)
- A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies (PHASE1)
- Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (PHASE2)
- Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents (PHASE1, PHASE2)
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:
- Second-Line Chemotherapy Agents CI brief — competitive landscape report
- Second-Line Chemotherapy Agents updates RSS · CI watch RSS
- Genentech, Inc. portfolio CI
Frequently asked questions about Second-Line Chemotherapy Agents
What is Second-Line Chemotherapy Agents?
Who makes Second-Line Chemotherapy Agents?
What development phase is Second-Line Chemotherapy Agents in?
Related
- Manufacturer: Genentech, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing