Specialty Pharma Journal Specialty, Precision & Technology
TOKYO, Nov. 28, 2018 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) approved XOSPATA® (generic name: gilteritinib) for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia …
Tag Archives: acute myeloid leukemia
November, 2018
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21 November
FDA Approves Pfizer’s Daurismo for Adults with Newly-Diagnosed Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not an Option
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved DAURISMO™ (glasdegib), a once-daily oral medicine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years or older or who have comorbidities that preclude use of intensive induction …
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21 November
FDA Grants Accelerated Approval to Venclexta for Newly-Diagnosed Acute Myeloid Leukemia or Patients Ineligible for Intensive Induction Chemo
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine (LDAC), for the treatment of people …
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21 November
FDA Grants Priority Review to Daiichi Sankyo’s Quizartinib for Treatment of Relapsed/Refractory FLT3-ITD Acute Myeloid Leukemia
TOKYO, MUNICH and BASKING RIDGE, N.J., Nov. 21, 2018 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute …
August, 2018
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27 August
FDA Grants Fast Track Designation to Cantex Pharmaceuticals’ Investigational CX-01 for Treatment of Acute Myeloid Leukemia
WESTON, Fla., Aug. 27, 2018 /PRNewswire/ — Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals for the treatment of cancer, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation for Cantex’s lead product candidate, CX-01, for the treatment of patients over …
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9 August
Jazz and MD Anderson Partner to Evaluate Potential Therapies for Hematologic Malignancies
DUBLIN and HOUSTON, Aug. 6, 2018 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and The University of Texas MD Anderson Cancer Center today announced a five-year collaboration agreement with a goal of evaluating therapies for multiple hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndromes. The joint effort brings …
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2 August
FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s Quizartinib for Relapsed/Refractory FLT3-ITD AML
Tokyo, Munich and Basking Ridge, NJ – (August 1, 2018) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). “There have …
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2 August
Astex and Otsuka Announce that Guadecitabine Fails to Meet Endpoints in Late-Stage AML Study
otsuk PLEASANTON, Calif. & TOKYO–(BUSINESS WIRE)–Astex Pharmaceuticals, a member of the Otsuka group of companies, and Otsuka Pharmaceutical Co. Ltd., announce top-line results from the ASTRAL-1 study evaluating the efficacy and safety of guadecitabine (SGI-110) in adults with previously untreated AML who are not eligible for intensive induction chemotherapy. The …
July, 2018
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23 July
FDA Approves Tibsovo, the First Targeted Treatment for Patients with Relapsed/Refractory AML with an IDH1 Mutation
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that TIBSOVO® (ivosidenib) was granted approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate …
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20 July
Positive Phase 3 Data of Jazz’s Vyxeos in Patients with Acute Myeloid Leukemia Published in Journal of Clinical Oncology
DUBLIN, July 19, 2018 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced today that data from the pivotal Phase 3 study of Vyxeos® (daunorubicin and cytarabine) liposome for injection compared to standard of care cytarabine and daunorubicin (7+3) were published online in the Journal of Clinical Oncology. The study evaluated the efficacy and safety …