SN-38
- Generic Name
- SN-38
- Brand Names
- Trodelvy
- Drug Type
- Small Molecule
- Chemical Formula
- C22H20N2O5
- CAS Number
- 86639-52-3
- Unique Ingredient Identifier
- 0H43101T0J
- Background
7-ethyl-10-hydroxycamptothecin (SN 38) is a liposomal formulation of the active metabolite of Irinotecan Irinotecan, a chemotherapeutic pro-drug approved for the treatment of advanced colorectal cancer. SN 38 has been used in trials studying the treatment of Cancer, Advanced Solid Tumors, Small Cell Lung Cancer, Metastatic Colorectal Cancer, and Triple Negat...
- Indication
Investigated for use/treatment in colorectal cancer.
- Associated Conditions
- Hormone Receptor Positive Metastatic Breast Cancer, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Triple Negative Breast Cancers, Unresectable Triple-Negative Breast Carcinoma, Metastatic HR Positive, HER2/Neu Negative Breast Cancer, Unresectable Locally Advanced Triple-negative Breast Cancer, Unresectable, locally advanced HR Positive, HER2/Neu Negative Breast Cancer, Unresectable, locally advanced Hormone Receptor Positive Breast Carcinoma
- Associated Therapies
- -
U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy sacituzumab govitecan hziy
Gilead Sciences announced FDA's Breakthrough Therapy Designation for Trodelvy for treating extensive-stage small cell lung cancer (ES-SCLC) post platinum-based chemotherapy. Based on Phase 2 TROPiCS-03 study results, Trodelvy showed promising antitumor activity and a consistent safety profile, prompting plans for a Phase 3 trial. Lung cancer, especially SCLC, has high mortality rates, and there's an urgent need for effective treatments.
Sacituzumab Govitecan-hziy Receives FDA Breakthrough Therapy Designation
The FDA granted breakthrough therapy designation to sacituzumab govitecan-hziy (Trodelvy; Gilead) for ES-SCLC, based on TROPiCS-03 trial data showing promising antitumor activity as a second-line treatment. The study reported an overall response rate of 41.9% and median overall survival of 13.60 months, with 97.7% of patients experiencing treatment-related adverse events.
Related Clinical Trials:
U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan
Trodelvy showed promising antitumor activity in ES-SCLC, including platinum-resistant and sensitive disease, with a safety profile consistent with previous studies. Gilead plans to initiate a Phase 3 trial in this patient population.
Gilead Sciences Inc (GILD) Receives FDA Breakthrough Therapy Designation
Gilead Sciences announced FDA Breakthrough Therapy Designation for Trodelvy® in treating extensive-stage small cell lung cancer (ES-SCLC) post-platinum chemotherapy, based on Phase 2 TROPiCS-03 study results. Trodelvy shows significant antitumor activity and consistent safety profile, with plans for a Phase 3 trial. Side effects include neutropenia and diarrhea.
FDA Grants Breakthrough Therapy Status To Gilead's Trodelvy For Treatment Of Small Cell Lung Cancer
Gilead Sciences announced FDA granted Breakthrough Therapy Designation to Trodelvy for treating extensive-stage small cell lung cancer based on Phase 2 TROPiCS-03 study results. Trodelvy is approved in over 40 countries for multiple breast cancer types and urothelial cancer.
FDA Grants Breakthrough Therapy Status To Gilead's Trodelvy For Treatment Of Small Cell
Gilead Sciences announces FDA Breakthrough Therapy Designation for Trodelvy in extensive-stage small cell lung cancer, based on Phase 2 TROPiCS-03 study results. Trodelvy is already approved for multiple breast cancers and urothelial cancer in over 40 countries.
FDA grants breakthrough status to Gilead's lung cancer drug
Gilead Sciences Inc. received FDA Breakthrough Therapy Designation for Trodelvy in treating extensive-stage small cell lung cancer. Trodelvy, a first-in-class Trop-2-directed antibody-drug conjugate, showed promising antitumor activity in Phase 2 TROPiCS-03 study. Gilead plans a Phase 3 trial for Trodelvy in ES-SCLC patients.
Drug Development Updates
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