Imkeldi (imatinib) / Shorla Oncology - LARVOL DELTA

AALL1631: Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P3 | N=352 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial primary completion date: Sep 2027 ➔ Jun 2026

Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • CSF1R • PDGFRA • PDGFRB

Shorla Oncology Announces Licensing Agreement and Strategic Partnership for Rights to Market Chemotherapy Drug, PIP-101, in the United States (Businesswire) - "Shorla Oncology...today announced it has entered into a licensing agreement and strategic partnership with a U.K.-based innovative drug development and manufacturing company. Under the terms of the agreement, Shorla will obtain an exclusive license from the developer to register and commercialize PIP-101, the first palatable oral solution of the related chemotherapeutic agent in the U.S....Under the terms of the agreement, the developer will continue to manufacture PIP-101. Once Shorla has obtained approval of its New Drug Application (NDA), the company will be responsible for the timely launch, commercialization and sales of PIP-101 in the U.S."

Licensing / partnership • Acute Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Onco360 Has Been Selected as a National Specialty Pharmacy Provider for IMKELDI (imatinib) Oral Solution (GlobeNewswire) - "...IMKELDI (imatinib) Oral Solution...[is] indicated for the treatment of newly diagnosed Philadelphia-positive (Ph+ CML) chronic myeloid leukemia, Ph+ CML in blast crisis, accelerated phase or chronic phase after interferon-alpha therapy, adult and pediatric patients with Ph+ ALL, myelodysplastic/myeloproliferative disease (MDS/MPD), aggressive systemic mastocytosis (ASM), Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL), Dermatofibrosarcoma Protuberans (DFSP), Kit+ Gastrointestinal Stromal Tumors (GIST), and adjuvant treatment of GIST."

Commercial • Acute Lymphocytic Leukemia • Aggressive Systemic Mastocytosis • Chronic Eosinophilic Leukemia • Chronic Myeloid Leukemia • Gastrointestinal Stromal Tumor • Hypereosinophilic Syndrome • Myelodysplastic Syndrome • Sarcoma

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: Mar 2026 ➔ Mar 2027

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

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