Takeda`s Iclusig wins first-line FDA nod to treat Ph+ALL
Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL
The efficacy and safety displayed by the combination of ponatinib (Iclusig) plus reduced intensity chemotherapy could alter the treatment paradigm for patients with newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL), according to Elias Jabbour, MD.
In November, Takeda said its blood cancer drug Iclusig topped Novartis’ Gleevec in a phase 3 trial in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).
OSAKA, Japan & CAMBRIDGE, Mass--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the randomized, Phase 3 PhALLCON trial met its primary endpoint, demonstrating that adult patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) treated with ICLUSIG® (ponatinib) plus reduced-intensity chemotherapy achieved higher rates of minimal residual disease (MRD)-negative complete remission (CR) compared to imatinib. MRD-negativity is associated with improvement in long-term outcomes for patients, as reported in literature. ICLUSIG is the only pan-mutational and third-generation tyrosine kinase inhibitor (TKI), targeting BCR::ABL1 and all known single, treatment-resistant mutations, including the most resistant T315I mutation.
The FDA approved the supplemental new drug application (sNDA) for ponatinib (Iclusig) to treat patients with chronic-phase chronic myeloid leukemia (CP-CML) with resistance or intolerance to at least 2 prior kinase inhibitors, according to Takeda Pharmaceutical Company.
The FDA approved the supplemental new drug application (sNDA) for ponatinib (Iclusig) to treat patients with chronic-phase chronic myeloid leukemia (CP-CML) with resistance or intolerance to at least 2 prior kinase inhibitors, according to Takeda Pharmaceutical Company.
HOUSTON, May 29, 2020 /PRNewswire/ -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced updated clinical results from an ongoing investigator-sponsored Phase 1 trial led by the Baylor College of Medicine, evaluating the Company's MultiTAA-specific T cell therapy in patients with advanced or metastatic pancreatic adenocarcinoma. Data from a cohort of patients receiving MultiTAA-specific T cell therapy in combination with standard-of-care chemotherapy in the first-line setting (Arm A), were reviewed today by lead investigator, Brandon G. Smaglo, M.D., FACP, as part of a poster session during the 2020 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting. ASCO is being held from Friday, May 29 through Sunday, May 31, 2020.
Cambridge, Mass. And Osaka, Japan, May 29, 2020 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that interim analysis data from the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial will be presented during an oral session at the virtual 56th American Society of Clinical Oncology (ASCO) Annual Meeting and the 25th European Hematology Association (EHA) Annual Meeting. The OPTIC trial is an ongoing, randomized, open-label study prospectively evaluating response-based dosing regimens of ICLUSIG® (ponatinib) over a range of three starting doses (45-, 30-, or 15-mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy.