Hypermagnesemia

VANFLYTA® Now Available in U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML

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Mercredi, août 9, 2023
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VANFLYTA was approved by the FDA on July 20, 2023 in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.

Key Points: 
  • VANFLYTA was approved by the FDA on July 20, 2023 in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.
  • The results of QuANTUM-First were published in The Lancet .1
    The safety of VANFLYTA was evaluated in 265 patients with newly diagnosed FLT3-ITD positive AML who received VANFLYTA once daily (35.4 mg with chemotherapy, 26.5 to 53 mg as maintenance) in the QuANTUM-First trial.
  • Daiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed VANFLYTA can access the medication and receive appropriate financial support.
  • Provider and patient support and information regarding distribution, access, and reimbursement are now available through Daiichi Sankyo Access Central by visiting www.DSIAccessCentral.com or calling 1-866-4-DSI-NOW (1-866-437-4669).

VANFLYTA® First FLT3 Inhibitor Approved in the U.S. Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

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Jeudi, juillet 20, 2023
Oncology, Health, FDA, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Magnesium, QT interval, Doctor of Philosophy, Alkaline phosphatase, Patient, Division, Risk, Daiichi Sankyo, HR, Leukemia, Nosebleed, Thrombocytopenia, REMS, Maintenance, Febrile neutropenia, Diarrhea, Pharmacy, Duke Cancer Institute, Sepsis, Vomiting, FLT3, Fungal infection, Lancet, Death, Headache, Safety, Neutropenia, Cardiac arrest, Indigestion, ECG, Abdominal pain, Acute myeloid leukemia, Insomnia, Lymphocytopenia, Anemia, CR, Mucositis, Hypermagnesemia, Hyperkalemia, Hypophosphatemia, Mitigation, Hypocalcemia, HSCT, QT, Bone marrow, AML, NE, Hypokalemia, Nausea, Hypernatremia, Upper respiratory tract infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, TSE, Pharmaceutical industry, Nursing, MD, Hypoalbuminemia

VANFLYTA will be available by prescription in the U.S. in the coming weeks.

Key Points: 
  • VANFLYTA will be available by prescription in the U.S. in the coming weeks.
  • VANFLYTA is approved with a Boxed WARNING for QT prolongation, torsades de pointes and cardiac arrest.
  • The FDA concurrently approved a companion diagnostic test to detect FLT3-ITD mutations in patients with newly diagnosed AML.
  • Daiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed VANFLYTA can access the medication and receive appropriate financial support.

Pfizer Announces Positive Topline Results from Phase 3 TALAPRO-2 Trial

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Mardi, octobre 4, 2022
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At the time of topline analysis, the safety of TALZENNA plus XTANDI were generally consistent with the known safety profile of each medicine.

Key Points: 
  • At the time of topline analysis, the safety of TALZENNA plus XTANDI were generally consistent with the known safety profile of each medicine.
  • Detailed results from TALAPRO-2 will be submitted for presentation at a near-term medical congress.
  • In addition to the TALAPRO-2 trial, the combination of TALZENNA plus XTANDI is being investigated in the TALAPRO-3 trial ( NCT04821622 ), a global, randomized, double-blind, placebo-controlled Phase 3 study in men with HRR-deficient mCSPC.
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Bristol Myers Squibb Announces Topline Results Showing Treatment with Orencia (abatacept) Improved Survival in People Hospitalized with COVID-19

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Jeudi, juin 2, 2022
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Given the positive findings from the topline data, Bristol Myers Squibb plans to discuss these data and potential next steps with the U.S. Food and Drug Administration.

Key Points: 
  • Given the positive findings from the topline data, Bristol Myers Squibb plans to discuss these data and potential next steps with the U.S. Food and Drug Administration.
  • Hypersensitivity: There were 2 cases (
  • For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram .
  • In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.