Merck Announces Breakthrough Therapy Designation for Lambrolizumab an Investigational Antibody Therapy for Advanced Melanoma

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting Programmed Death receptor (PD-1) that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types.”


Bavarian Nordic Agrees on Interim Analysis with the FDA and Provides an Update on its PROSPECT Phase 3 Trial

KVISTGAARD, Denmark — Bavarian Nordic A/S (OMX: BAVA) today announced that the Company plans to conduct an interim analysis of the on-going PROSPECT Phase 3 trial of PROSTVAC(r) in prostate cancer patients …


Cancer Drug Shortages in the U.S. Are Harmful and Costly

Cancer drug shortages are widespread and have tangible negative effects, according to a nationwide survey of U.S. health professionals who manage cancer drugs. Ninety-eight percent of those surveyed had experienced a shortage of at least one essential cancer-related drug in the past year; 93% reported that these shortages resulted in delays or changes in treatment. Sixteen percent said the shortages had detrimental effects, such as disease progression or treatment complications, including one death due to a medication mistake. Drug shortages can also disrupt clinical trials and increase health care costs by driving up drug prices and tying up health care provider time. Federal legislation was passed in 2012 to enable the FDA to better address drug shortages, but the study’s authors believe that further action is needed. Full survey report at: http://www.ajhp.org/content/70/7/609.abstract


Cancer Drug Shortages in the U.S. Are Harmful and Costly

Cancer drug shortages are widespread and have tangible negative effects, according to a nationwide survey of U.S. health professionals who manage cancer drugs. Ninety-eight percent of those surveyed had experienced a shortage of at least one essential cancer-related drug in the past year; 93% reported that these shortages resulted in delays or changes in treatment. Sixteen percent said the shortages had detrimental effects, such as disease progression or treatment complications, including one death due to a medication mistake. Drug shortages can also disrupt clinical trials and increase health care costs by driving up drug prices and tying up health care provider time. Federal legislation was passed in 2012 to enable the FDA to better address drug shortages, but the study’s authors believe that further action is needed. Full survey report at: http://www.ajhp.org/content/70/7/609.abstract


Cancer Drug Shortages in the U.S. are Harmful and Costly

Cancer drug shortages are widespread and have tangible negative effects, according to a nationwide survey of U.S. health professionals who manage cancer drugs. Ninety-eight percent of those surveyed had experienced a shortage of at least one essential cancer-related drug in the past year, and 93% reported that these shortages resulted in delays or changes in treatment. Sixteen percent said the shortages had detrimental effects, such as disease progression or treatment complications, including one death due to a medication mistake. Drug shortages can also disrupt clinical trials and increase healthcare costs by driving up drug prices and tying up healthcare provider time. Federal legislation was passed in 2012 to enable the FDA to better address drug shortages, but the study’s authors believe that further action is needed. Full survey report available at: http://www.ajhp.org/content/70/7/609.abstract


Immunotherapies Take Center Stage in Treatment of Metastatic Melanoma


The promise of immunotherapy is coming to fruition with therapeutic advances in melanoma. In 1998, high-dose interleukin-2 (HD IL-2) became the first U.S. Food and Drug Administration (FDA)-approved immunotherapy for metastatic melanoma. But HD IL-2 is severely toxic and benefits only a small minority of patients. In 2011, ipilimumab became the second immunotherapy approved for metastatic melanoma. Continue reading…


FDA Fast-Tracks Approval Process for Lung Cancer Drug LDK378

The FDA has designated Novartis’s anti-cancer drug LDK378 as a breakthrough therapy, thereby placing it on a faster track for FDA approval. “Breakthrough therapy” is a status reserved for drugs that treat serious conditions and that have been shown in preliminary studies to provide a substantial improvement over currently available treatments. In addition to the drug being eligible for accelerated approval, a company producing a breakthrough therapy receives more guidance from the FDA throughout drug development. LDK378, which inhibits a protein called ALK, is designed to treat non-small cell lung cancer (NSCLC) with a mutation in the ALK gene. It may be effective in patients with ALK-mutant NSCLC who have become resistant to the ALK inhibitor crizotinib (Xalkori).


FDA seeks to fast track Novartis lung cancer drug

“The U.S. Food and Drug Administration has designated a compound developed by Novartis AG to treat a type of non-small cell lung cancer for fast-track development and review, the Swiss drugmaker said on Friday.”


FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers

“The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.”