Tag Archives: Blood Cancer

July, 2018

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 …
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1 June
Amgen and MD Anderson Announce Two Collaboration Agreements to Accelerate Development of Various Cancer Therapies

THOUSAND OAKS, Calif. and HOUSTON, May 31, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) and The University of Texas MD Anderson Cancer Center today announced two multi-year collaboration agreements aimed at accelerating development of a variety of Amgen’s early-stage oncology therapies for patients with leukemia, myelodysplastic syndromes, multiple myeloma, small-cell lung cancer, and other non-lung cancers with small-cell histologies. The agreements combine Amgen therapies …
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25 January
Pfizer Announces Positive Top-Line Results for Potential Biosimilar to Rituxan/MabThera

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera® (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan® (rituximab-US)/MabThera®1. The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of …
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18 January
FDA Approves Addition of Overall Survival Data to Kyprolis Label

THOUSAND OAKS, Calif., Jan. 17, 2018 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS® (carfilzomib). Data …
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28 November
Astellas to Present New Data Evaluating Gilteritinib in Newly Diagnosed AML Patients

TOKYO, Nov. 28, 2017 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) today announced new data in acute myeloid leukemia (AML) research, including preliminary results from a Phase 1 study of the investigational agent gilteritinib in combination with induction and consolidation chemotherapy in patients with …
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6 November
FDA Approves Genentech’s Zelboraf for Treatment of Patients with a Rare Blood Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Zelboraf® (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a rare, serious blood disease characterized by the abnormal multiplication of …
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26 October
Amgen’s Kyprolis Meets Primary Endpoint in Phase 3 Study in Relapsed and Refractory Multiple Myeloma

THOUSAND OAKS, Calif., Oct. 23, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced top-line results of the Phase 3 A.R.R.O.W. trial, which showed KYPROLIS® (carfilzomib) administered once-weekly at the 70 mg/m2 dose with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening …
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6 October
Researchers Identify Genetic Drivers of Most Common Form of Lymphoma

DURHAM, N.C. — Lymphoma is the most common blood cancer, but the diagnosis belies a wildly diverse and little understood genetic foundation for the disease that hampers successful treatment. An international research effort led by Duke Cancer Institute scientists has been working to better understand the genetic underpinnings of the …
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13 September
FDA Accepts for Review Sandoz’s BLA for Proposed Biosimilar Rituximab

Holzkirchen, September 12, 2017 – Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan®** (rituximab). Rituxan®** is used to …
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7 September
FDA Places Clinical Hold on Celgene’s Fusion Clinical Program

SUMMIT, N.J.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on five trials and a full clinical hold on one trial in the Celgene FUSION™ program. The trials are testing IMFINZI™ (durvalumab), an anti-PD-L1 antibody, in combination with immunomodulatory and chemotherapy agents …
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