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Oncology

Bristol-Myers’ Opdivo Granted Priority Review from the FDA for Treatment of Hepatocellular Carcinoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy. The FDA granted the application priority review and previously granted …

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FDA Advisory Committee Recommends Approval of Puma Biotech’s Breast Cancer Drug

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 – 4 to recommend approval of PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that …

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President’s Budget Threatens to Stall Nation’s Progress Against Cancer

ASCO strongly opposes the Administration’s proposed cuts to federal agencies that support biomedical research and Medicaid for Fiscal Year 2018, including a 21 percent proposed funding cut for the National Institutes of Health (NIH), a 20 percent proposed funding cut for the National Cancer Institute (NCI), and reducing Medicaid funding …

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FDA Grants Accelerated Approval to Merck’s Keytruda for Solid Tumors with Specific Biomarkers

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy. KEYTRUDA is now indicated for the treatment of adult and pediatric patients with unresectable or metastatic, …

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One in Five Cancers Diagnosed in the United States is a Rare Cancer

About one in five cancer diagnoses in the United States is a rare cancer, according to a new American Cancer Society report. The report, appearing in CA: A Cancer Journal for Clinicians, a peer-reviewed journal of the American Cancer Society, finds rare cancers account for more than two in three …

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Nektar and Takeda Enter Research Deal Exploring Combination Cancer Therapy Approaches

SAN FRANCISCO, May 22, 2017 /PRNewswire/ — Nektar Therapeutics (NASDAQ: NKTR) announced today that Takeda Pharmaceutical Company Limited (TSE: 4502) and Nektar have entered into a research collaboration to explore the combination of Nektar’s lead immuno-oncology candidate, the CD122-biased agonist NKTR-214, with five oncology compounds from Takeda’s cancer portfolio.  The …

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Targeted Therapy Can Delay Recurrence of Intermediate-Stage Lung Cancer

ASCO Perspective “This study identifies a subset of patients with lung cancer who can benefit from a targeted treatment that causes far fewer side effects than chemotherapy,” said ASCO President-Elect Bruce E. Johnson, MD, FASCO. “It’s also clear evidence that we can use precision medicine not only in patients with …

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GlycoMimetics’ Investigational Acute Myeloid Leukemia Drug Receives Breakthrough Therapy Designation from the FDA

ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (NASDAQ: GLYC) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for treatment of adult relapsed/refractory acute myeloid leukemia (AML) to the company’s drug candidate GMI-1271, an E-selectin antagonist currently being evaluated in the Phase 2 portion of a Phase …

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FDA Approves Merck’s Keytruda for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In …

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Cinfa’s Pegfilgrastim Biosimilar Candidate Demonstrates Positive Results in Second Clinical Study

PAMPLONA, Spain | May 17, 2017 | Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced positive top-line data from the second clinical trial with its lead development candidate B12019, a biosimilar version of Neulasta(R)(pegfilgrastim) to treat chemotherapy-induced neutropenia. The trial demonstrated comparability of B12019 and its reference product Neulasta …

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