Imkeldi (imatinib) / Shorla Oncology - LARVOL DELTA

Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia (clinicaltrials.gov) - P2 | N=406 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2025 ➔ Mar 2026

Trial completion date • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR

Shorla Oncology Announces Expansion of U.S. Commercial Footprint with Launch of Dedicated Sales Force and Market Access Teams (Businesswire) - "Shorla Oncology...announced the launch of a dedicated sales force and market access teams and the commercial availability of IMKELDI, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers....As part of its patient support efforts, Shorla has partnered with EVERSANA’s specialty pharmacy to dispense IMKELDI free of charge to eligible uninsured patients through its Patient Assistance Program (PAP)."

Commercial • Acute Lymphocytic Leukemia • Chronic Myeloid Leukemia • Gastrointestinal Cancer • Myelodysplastic Syndrome

Shorla Oncology Announces FDA Approval of IMKELDI (imatinib) Oral Solution, an Oral Liquid for the Treatment of Certain Forms of Leukemia and Other Cancers (Businesswire) - "Shorla Oncology...announced today that the FDA has approved IMKELDI (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers....IMKELDI can help slow or prevent the growth of specific cancers, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia, myelodysplastic syndrome /myeloproliferative disease (MDS/MPD), and gastrointestinal tumors (GIST)."

FDA approval • B Acute Lymphoblastic Leukemia • Chronic Myeloid Leukemia • Gastrointestinal Stromal Tumor • Myelodysplastic Syndrome

Shorla Oncology Announces FDA Filing Acceptance of New Drug Application to Treat Certain Forms of Leukemia and Other Cancers (Businesswire) - "Shorla Oncology...announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers. The Agency assigned a Prescription Drug User Fee Act ('PDUFA') action date of November 30, 2024."

NDA • PDUFA date • Hematological Malignancies • Leukemia • Oncology