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.”


FDA Approves Automated Scanning System for ALK Gene Mutations

Three percent to 5% of non-small cell lung cancer (NSCLC) patients have a mutation in the ALK gene and may benefit from treatment with critozinib (Xalkori). In 2011, the FDA approved a test that samples NSCLC tissue and highlights ALK mutations with a glowing tag. Now, the FDA has approved an automated scanning system, GenASIs Scan & Analysis, for examining these tagged tissue samples. The automated system, produced by Applied Spectral Imaging, promises fast, reliable detection of ALK mutations in NSCLC.

Press release: http://www.spectral-imaging.com/news-and-events/news?elq=666b179d69bb426e96e2bb8761261d25


World's First FDA Cleared ALK Automated Gene Scanner for Lung Cancer Therapy-Selection Available from ASI

Applied Spectral Imaging (ASI, www.spectral-imaging.com) announced today that its GenASIs Scan & Analysis automated microscopy platform has received FDA clearance as an aid in ALK gene analysis for lung cancer therapy selection. The introduction of automation in ALK therapy selection represents a new era in personalized medicine for patients with NSCLC (Non-Small-Cell-Lung-Cancer).

GenASIs Scan & Analysis offers clinicians a way to automatically perform genetic analysis on tissue samples, stained with the Abbott ALK™ probe kit, and identify the ALK gene rearrangement.