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Oncology

Alternative Splicing, An Important Mechanism for Cancer

Barcelona, 21 September 2017 – Cancer, which is one of the leading causes of death worldwide, arises from the disruption of essential mechanisms of the normal cell life cycle, such as replication control, DNA repair and cell death. Thanks to the advances in genome sequencing techniques, biomedical researchers have been …

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AbbVie Announces Another Combination Trial Evaluating New ADC with Bristol-Myers Squibb’s Opdivo

NORTH CHICAGO, Ill. & NEW YORK–(BUSINESS WIRE)–AbbVie (NYSE: ABBV) and Bristol-Myers Squibb Company (NYSE: BMY) today announced a clinical trial collaboration to evaluate the combination of AbbVie’s investigational antibody drug conjugate ABBV-399 and Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) in c-Met overexpressing non-small cell lung cancer (NSCLC). A Phase 1b clinical study is underway that includes …

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‘Labyrinth’ Chip Could Help Monitor Aggressive Cancer Stem Cells

ANN ARBOR–Inspired by the Labyrinth of Greek mythology, a new chip etched with fluid channels sends blood samples through a hydrodynamic maze to separate out rare circulating cancer cells into a relatively clean stream for analysis. It is already in use in a breast cancer clinical trial. Tumor cells isolated …

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FDA Advisory Committee Split on Opinion of Adjuvant Sutent for High-Risk Renal Cell Carcinoma

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 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical …

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AbbVie Announces Positive Results from Late-Stage Relapsed/Refractory Chronic Lymphocytic Leukemia Study

NORTH CHICAGO, Ill., Sept. 18, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Phase 3 MURANO study of VENCLEXTA™/VENCLYXTO™ (Venetoclax) Tablets in combination with Rituxan® (rituximab) met its primary endpoint. Results showed that VENCLEXTA/VENCLYXTO in combination with Rituxan prolonged progression-free survival (PFS) in patients with relapsed/refractory (R/R) chronic …

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FDA Approves Bayer’s Aliqopa for Treatment of Relapsed Follicular Lymphoma

WHIPPANY, N.J., Sept. 14, 2017 /PRNewswire/ — Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Aliqopa™ (copanlisib) for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies.1 Accelerated approval was granted for this indication based on ORR. …

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FDA Approves Amgen and Allergan’s Mvasi for the Treatment of Five Types of Cancer

THOUSAND OAKS, Calif., Sept. 14, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved MVASI™ (bevacizumab-awwb) for all eligible indications of the reference product, Avastin® (bevacizumab). MVASI is the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, approved by the FDA. MVASI is …

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Daiichi Sankyo and MD Anderson Collaborate to Accelerate Development of Acute Myeloid Leukemia Therapies

HOUSTON and TOKYO and BASKING RIDGE, N.J., Sept. 14, 2017 /PRNewswire/ — The University of Texas MD Anderson Cancer Center and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced a multi-year collaboration focused on accelerating the development of novel therapies for acute myeloid leukemia (AML). The collaboration represents an …

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Pfizer and Astellas Announce Positive Late-Stage Results for Xtandi in Non-Metastatic Castration-Resistance Prostate Cancer

NEW YORK & TOKYO–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the Phase 3 PROSPER trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC) met its primary endpoint …

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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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