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Oncology

FDA Grants Orphan Drug Designation to Astellas’ Gilteritinib for Treatment of Acute Myeloid Leukemia

TOKYO, July 20, 2017 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) granted orphan-drug designation to gilteritinib in patients with acute myeloid leukemia (AML). The Orphan Drug Designation program assigns status to drugs and biologics …

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Kite’s CAR-T Cell Therapy Demonstrates Positive Results in Patients with Chemorefractory Aggressive NHL

SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, highlighted the recent online publication of results in Molecular Therapy from a National Cancer Institute (NCI) study of anti-CD19 chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive NHL including diffuse large B-cell lymphoma (DLBCL). The research, led by James …

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FDA Approves Puma’s Nerlynx for Early Stage HER2-Positive Breast Cancer

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (Nasdaq: PBYI) today announced that the U.S. Food and Drug Administration (FDA) has approved NERLYNX™ (neratinib), formerly known as PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. Puma expects neratinib …

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Side Effects Not A Major Problem for New Class of Breast Cancer Drugs

A ground-breaking new class of oral drugs for treating breast cancer, known as cyclin-dependent kinase (CDK) inhibitors, are generally well-tolerated, with a manageable toxicity profile for most patients. This is the conclusion of a comprehensive review of toxicities and drug interactions related to this class of drugs, recently published in The …

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FDA Committee Recommends Approval of Mylan and Biocon’s Proposed Biosimilar Trastuzumab

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, July 13, 2017/PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies’ proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible …

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Amgen’s Kyprolis Regimen Significantly Improves Overall Survival in Multiple Myeloma Patients in Second Phase 3 Study

THOUSAND OAKS, Calif., July 12, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced positive results from the final analysis of the Phase 3 ASPIRE trial. The study met the key secondary endpoint of overall survival (OS), demonstrating that KYPROLIS® (carfilzomib), lenalidomide and dexamethasone (KRd) reduced the risk of death by …

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FDA Committee Recommends Approval for Novartis’ CAR-T Cell Therapy for Acute Lymphoblastic Leukemia

Basel, July 12, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell …

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FDA Advisory Committee Votes in Favor of Pfizer’s Mylotarg for Acute Myeloid Leukemia

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted that the results of ALFA-0701 demonstrated a favorable risk:benefit profile for MYLOTARG (gemtuzumab ozogamicin) 3 mg/m2 on days 1, 4 and 7 added to chemotherapy for patients with newly-diagnosed CD33-positive …

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NYU Langone Launches Major Interdisciplinary Program Targeting Pancreatic Cancer

NEW YORK, July 10, 2017 /PRNewswire-USNewswire/ — Perlmutter Cancer Center at NYU Langone has announced the creation of a multidisciplinary center of excellence to develop innovative approaches to diagnose, treat and prevent pancreatic cancer. The new Pancreatic Cancer Center brings together laboratory researchers, surgeons, oncologists, geneticists and others throughout NYU …

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PDS Biotechnology and Merck to Evaluate Combination of Versamune PDS0101 and Keytruda in Head and Neck Cancer

NORTH BRUNSWICK, N.J., July 10, 2017 /PRNewswire/ — PDS Biotechnology Corporation (“PDS”), a private clinical stage immuno-oncology company developing novel immunotherapies, has entered a clinical trial collaboration agreement with a subsidiary of Merck (known as MSD outside the United States and Canada) to evaluate the combination of PDS’s lead Versamune®-based …

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