Neuroendocrine tumors of the digestive system (GI-NETs) can arise in different parts of the digestive tract. GI-NETs originating in the ileum, duodenum, and appendix are known as midgut NETs, and tumors of the stomach, colon, and rectum are non-midgut NETs. Many of these tumors are functional; that is, they produce a variety of hormonal substances that cause serious, debilitating symptoms. Continue reading…
“Merck MRK, -0.23% known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. The FDA granted Priority Review with a PDUFA, or target action, date of October 2, 2015; the sBLA will be reviewed under the FDA’s Accelerated Approval program.
“ ‘Today’s announcement reflects our commitment to accelerate the development of immunotherapeutic approaches to treat lung cancer, one of the most deadly malignancies,’ said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. ‘We believe that data submitted to the FDA illustrate the significant potential of KEYTRUDA to treat advanced non-small cell lung cancer – and we look forward to working with the FDA to bring our anti-PD-1 therapy to patients afflicted with this devastating cancer.’ “
“The FDA granted orphan drug designation to the WT1 cancer vaccine for the treatment of malignant pleural mesothelioma.
“The FDA based the designation on results from a randomized, double blind, placebo-controlled phase 2 trial of the WT1 vaccine (SLS-001, SELLAS Life Sciences) in 40 patients with malignant pleural mesothelioma treated at Memorial Sloan Kettering Cancer Center and The University of Texas MD Anderson Cancer Center.
“Results showed patients assigned the vaccine experienced longer median OS (21.4 months vs. 16.6 months) and median PFS (11.4 months vs. 5.7 months) than those assigned placebo. The vaccine also demonstrated a favorable safety profile, according to researchers.
“A phase 2b/3 trial in malignant pleural mesothelioma is expected to begin by the third quarter of this year.”
“Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
“The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.
“ ‘We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib,’ said Patrick J. Mahaffy, President and CEO of Clovis Oncology. ‘New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer.’ “
“The FDA granted orphan drug designation to IMCgp100 for the treatment of uveal melanoma.
“IMCgp100 (Immunocore) is part of a class of bispecific biologic reagents known as ImmTACs, or immune-mobilizing monoclonal T-cell receptors against cancer.
“The agents combine a T-cell receptor-based targeting system with an anti-CD3 effector function designed to activate a specific and potent T-cell response to recognize and destroy cancer cells, according to Immunocore.”