Tepylute (thiotepa ready to dilute) / Shorla Oncology - LARVOL DELTA

COG-ACNS0334: Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma (clinicaltrials.gov) - P3 | N=91 | Completed | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Completed | Trial completion date: Dec 2028 ➔ Sep 2025

Trial completion • Trial completion date • Brain Cancer • Embryonal Tumor • Medulloblastoma • Oncology • Solid Tumor • Transplantation • IGF1

NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Ganglioneuroblastoma • Neuroblastoma • Oncology • Solid Tumor • MYCN

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov) - P3 | N=750 | Recruiting | Sponsor: Children's Oncology Group | Trial completion date: Sep 2026 ➔ Sep 2030 | Trial primary completion date: Sep 2026 ➔ Sep 2030

Trial completion date • Trial primary completion date • Ganglioneuroblastoma • Neuroblastoma • Oncology • Solid Tumor • MYCN

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov) - P3 | N=750 | Recruiting | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Recruiting

Enrollment open • Ganglioneuroblastoma • Neuroblastoma • Oncology • Solid Tumor • MYCN

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Embryonal Tumor • Germ Cell Tumors • Oncology • Solid Tumor • NF1

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Children's Oncology Group | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • Embryonal Tumor • Germ Cell Tumors • Oncology • Solid Tumor • NF1

Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov) - P3 | N=435 | Active, not recruiting | Sponsor: Children's Oncology Group | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2027 ➔ Jun 2026 | Trial primary completion date: Dec 2027 ➔ Jun 2026

Enrollment closed • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • ABL1 • BCR • CEBPA • FLT3 • HLA-B • HLA-C • HLA-DQB1 • HLA-DRB1 • NPM1

Shorla Oncology Announces FDA Approval of TEPYLUTE 100mg, First and Only Ready-to-Dilute Multi-Dose Vial of Thiotepa to Treat Breast and Ovarian Cancer and Commercial Launch of TEPYLUTE 15mg and 100mg Vials in the U.S. (Businesswire) - "Shorla Oncology...announced today that the U.S. Food and Drug Administration has granted approval for 100 mg/10mL multi-dose vial of TEPYLUTE, a ready-to-dilute formulation of thiotepa to treat breast and ovarian cancer, that eliminates the need for reconstitution and may reduce preparation time and errors offering more scheduling flexibility for their patients....TEPYLUTE is Shorla Oncology’s fourth launch in the U.S. Market."

FDA approval • Launch US • Breast Cancer • Ovarian Cancer

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma (clinicaltrials.gov) - P3 | N=60 | Completed | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Dec 2024

Trial completion • Trial completion date • Bone Marrow Transplantation • Eye Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Transplantation

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma (clinicaltrials.gov) - P3 | N=60 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Bone Marrow Transplantation • Eye Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Transplantation

NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2024 ➔ Sep 2025

Trial completion date • CNS Tumor • Ganglioneuroblastoma • Neuroblastoma • Oncology • Solid Tumor • CXCL9 • IL6 • MYCN

Shorla Oncology Announces FDA Approval for TEPYLUTE, A Novel Formulation to Treat Breast and Ovarian Cancer (Businesswire) - "Shorla Oncology...announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for TEPYLUTE, a ready-to-dilute formulation to treat breast and ovarian cancer in an easier to prepare, injectable product that enables dosing accuracy."

FDA approval • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Shorla Oncology Announces FDA Filing Acceptance of New Drug Application for Novel Formulation to Treat Breast and Ovarian Cancer (Businesswire) - "Shorla Oncology...announced today that the US Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for a novel formulation to treat breast and ovarian cancer. The Agency assigned a Prescription Drug User Fee Act ('PDUFA') action date of June 29th, 2024....SH-105 is a ready-to-dilute form of a well-established drug that has been used as a freeze-dried powder since the 1950s and has seen supply shortages."

NDA • PDUFA date • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor