Articles

Munich, Germany—For patients with newly diagnosed metastatic prostate cancer, current standard management is androgen-deprivation therapy plus docetaxel (Taxotere). Contrary to previous assumptions, radiation to the primary tumor improves survival in men with low metastatic disease burden. This new finding came from the preplanned analysis of the multiarm, multistage STAMPEDE study presented at the ESMO 2018 Congress by lead investigator Chris C. Parker, MD, FRCR, MRCP, Consultant Clinical Oncologist, Royal Marsden NHS Foundation Trust, Sutton, England. The study was simultaneously published online in Lancet.¹ Read More ›

San Diego, CA—The BCL2 Gly101Val mutation is the first genomic alteration to be identified as responsible for resistance to venetoclax (Venclexta), a potent and effective medication indicated for the treatment of chronic lymphocytic leukemia (CLL). The BCL2 Gly101Val mutation is unique to CLL and so far has not been described in other cancers. Read More ›

San Diego, CA—Front-line ibrutinib (Imbruvica) therapy results in a lower rate of disease progression or death than the current standard-of-care chemoimmunotherapy with bendamustine (Bendeka) and rituximab (Rituxan) in older patients with chronic lymphocytic leukemia (CLL). Adding rituximab to ibrutinib did not improve outcomes compared with ibrutinib alone, reported Jennifer A. Woyach, MD, Associate Professor, Ohio State University Comprehensive Cancer Center, Columbus, at ASH 2018. Read More ›

San Diego, CA—More than 40% of older patients with acute myeloid leukemia (AML) associated with an IDH2 mutation achieved complete remission when treated with the IDH2 inhibitor enasidenib (Idhifa), according to results of a mutation-driven clinical trial substudy presented at ASH 2018. Read More ›

Munich, Germany—Long-term therapy with olaparib (Lynparza), a poly (ADP ribose) polymerase (PARP) inhibitor, in women with newly diagnosed advanced ovarian cancer and a BRCA1 or BRCA2 mutation led to a significant, unprecedented improvement in progression-free survival (PFS), reducing the risk for disease progression or death by 70% compared with placebo, according to results of the phase 3 SOLO-1 clinical trial. Read More ›

On February 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. This was the fourth approval pembrolizumab has received in the United States for the treatment of skin cancer, and the first FDA approval in the adjuvant setting. Read More ›

On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients with MM and is the first to be approved for the split-dosing regimen. This new regimen gives patients and healthcare providers the option to split the first dose of Darzalex over the course of 2 consecutive days, which has the benefit of shortening the duration of the first infusion. Read More ›

• FDA Approves First Therapy for the Treatment of Adult Patients with a Rare Blood Clotting Disorder
• FDA Issues Letter to Healthcare Providers Alerting Them to a Risk for Breast Implant Associated–Anaplastic Large-Cell Lymphoma

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• FDA Resumes Operations After Government Shutdown Ends
• FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma
• FDA Approves Pembrolizumab for Merkel-Cell Carcinoma

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Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold. Read More ›