FDA approves Imbruvica for mantle cell lymphoma
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.
The FDA announced the approval of Imbruvica (ibrutinib), marketed by Pharmacyclics and Johnson & Johnson, for treating mantle cell lymphoma, or MCL. MCL is a rare form of non-Hodgkin lymphoma and represents about 6% of all non-Hodgkin lymphoma cases in the United States. Millennium Pharmaceuticals’ Velcade (bortezomib) and Celgene’s Revlimid (lenalidomide) are also approved for treating MCL.
Imbruvica is the second drug with the FDA’s breakthrough therapy designation to receive approval from the agency. The FDA Safety and Innovation Act, passed in July 2012, gave the agency the ability to designate a drug a breakthrough therapy at the request of the company seeking approval if preliminary clinical evidence indicates it may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. Genentech’s Gazyva (obinutuzumab), for chronic lymphocytic leukemia, was the first designated breakthrough therapy to receive FDA approval, earlier this month.
"Imbruvica’s approval demonstrates the FDA’s commitment to making treatments available to patients with rare diseases," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "The agency worked cooperatively with the companies to expedite the drug’s development, review and approval, reflecting the promise of the Breakthrough Therapy Designation program."
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New cholesterol, obesity guidelines give greater role to statins, call for more research into weight-loss drugs
WASHINGTON — Greater use of statins in reducing the risk of high cholesterol is among the long-awaited new guidelines for treating lipid and weight disorders.
The new guidelines, summarized Tuesday on the American Pharmacists Association’s website, include stronger recommendations for using statins over other lipid-lowering drugs, a new risk calculator and a call for more research into weight-loss medications, while getting rid of LDL cholesterol targets and the Framingham risk assessment, which measures coronary heart disease risk. The guidelines cover treatment of cholesterol, lifestyle management to reduce cardiovascular risk, managing overweight and obesity and assessing cardiovascular risk.
"We’re simply saying how you get the LDL low is important," Northwestern University medical professor and chairman of the expert panel that wrote the cholesterol guideline Neil Stone said. "Considering all the possible treatments, we recommend a heart-healthy lifestyle and statin therapy for the best chance of reducing your risk of stroke or heart attack in the next 10 years."
The APhA has endorsed three of the four guidelines and is reviewing the recommendations on risk assessment, the group said. The manuscript versions of the four reports are available for pharmacists on the Journal of the American Pharmacists Association website.
Stone said an extensive review did not find solid evidence to support continued use of specific LDL-C or non-HDL-C treatment targets, and the guideline on lipids tailors recommendations to patients’ own cardiovascular risk where treatment benefit clearly outweighs the risk of adverse effects. Moderate- to high-intensity statin therapy is now recommended for patients 75 years and older with clinical cardiovascular disease; patients with LDL-C of 190-mg per decaliter of blood or more; patients ages 40 years to 75 years with diabetes; and patients ages 40 years to 75 years with an estimated 10-year cardiovascular risk of 7.5% or more whose LDL-C falls between 70-mg and 189-mg per decaliter of blood.
"Statins were chosen because their use has resulted in the greatest benefit and the lowest rates of safety issues," Stone said. "No other cholesterol-lowering drug is as effective as statins."
The new guideline on obesity advises clinicians and patients to measure weight frequently and avoid weight gain by adjusting food intake immediately after a few pounds are gained. No specific diet was recommended over another, but the guideline does support looking into weight-reducing drugs.
"What we didn’t cover was a critical question of pharmacotherapy," obesity writing committee co-chairwoman and Louisiana State University professor emeritus Donna Ryan said. "When these critical questions were developed, the only medications available were sibutramine and orlistat, and sibutramine was coming off the market. We think this is an opportunity for future guidelines."
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Sen. Harkin has ‘high hopes’ for drug safety bill
WASHINGTON — The chairman of the Senate Health, Education, Labor and Pensions Committee highlighted the human tragedy wrought by last year’s fungal meningitis outbreak linked to contaminated injectable steroids as he spoke in favor of a new law that would regulate compounding pharmacies and implement federal track-and-trace policies for drugs during a recent speech.
Sen. Tom Harkin, D-Iowa, expressed "high hopes" that the Senate would vote to enact the Drug Quality and Security Act, which is designed to ensure the safety of compounded drugs and secure the pharmaceutical supply chain and was cosponsored by Senate HELP Committee ranking member Lamar Alexander, R-Tenn. The bill has received support from the National Association of Chain Drug Stores, the National Community Pharmacists Association and the Generic Pharmaceutical Association.
"The 751 patients who were sickened by contaminated injections sold by [the New England Compoundint Center] and the families of the 64 who have died have lived a nightmare over this past year," Harkin said in the speech. "The medicine that was supposed to help them made them gravely ill or, in far too many cases, took their lives."
Harkin highlighted the cases of four patients who have had to quit their jobs due to unrelenting chronic pain, whose children have had to quit their jobs to take care of them, or who have lost their lives. He called the compounding provisions in the legislation an "unqualified step forward" from current law and practice, emphasizing that it distinguishes between traditional compounding and compounding that produces large volumes of drugs without individual prescriptions. Under the law, compounding pharmacies that perform such outsourcing services would be subject to Food and Drug Administration regulations, while those that engage in traditional compounding would continue to be regulated by the state boards of pharmacy.
Meanwhile, the bill’s track-and-trace provisions "will revolutionize the pharmaceutical supply chain," Harkin said, saying it would complete the work of last year’s FDA user-fee bill, which includes provisions to modernize the FDA’s authority regarding the so-called upstream supply chain, meaning the path of drugs from raw materials to finished products. The new bill, Harkin said, would modernize the downstream supply chain, meaning the path drugs take from manufacturers to providers and patients.
"The last comprehensive effort to establish safeguards for the drug distribution supply chain was 25 years ago," Harkin said.
Title II of the Bill is a real problem. Given the history of drug counterfeiting it is very likely there will be a highly publicized drug counterfeiting issue before the next congressional elections. Last fall counterfeit cancer medication meant that cancer patients were not receiving active medication. In the past, patients were killed when heparin was counterfeited, children killed when cough syrup contained the main ingredient of antifreeze, etc. Senators who approve of the nicely titled Drug Quality and Security Act (DQSA), H.R. 3204, will likely have to explain Title II of the Bill and why they allowed Big Pharma and Drug Wholesalers to get away with weak controls of prescription drug trade. Try explaining that to the parents of a child harmed by counterfeiting. Someone in the media will likely point out how weak the US drug controls are when compared with other countries. While Mr. Reid praises Title I of the Bill to control compounding he completely ignores how damaging Title II is to assuring the safety and authenticity of the US prescription drug trade. This is likely due to the extensive lobby effort to slip Title II of the Bill through by including something many wanted in the form of Title I of the Bill. It is much harder to defend Title II because many other countries require prescription drugs to be individually serialized and each sale of the drug to be certified and tracked. If H.R.3204 is passed the US will delay implementation of drug tracking by 10-years. The US drug supply tracking controls will be weaker than Turkey, China, Europe and several other countries. Why should the US citizens tolerate this or compromise? This should be part of the debate. If a Senator is seeking election or believes US patients deserve better, we implore them to break H.R.3204 into two separate Bills and consider compounding controls (Title I) and drug supply chain controls (Title II) separately. We further ask that they require guidance from the FDA for drug tracking in 2 years instead of 10 years and implementation by 2017. This would at least bring the US in line with other countries. Another unmentioned irony is that drug companies will have to serialize and track drugs for other countries and are upgrading their systems to do this now, but H.R. 3204 will allow them to avoid using those systems to protect US citizens. In fact, because the tracking requirements will be defined over the next 10 years, drug companies will not invest in tracking drugs in the US out of concerns that the FDA will require something different and they will have to throw away their investment in favor of something else. All the FDA needs to do is consider the tracking model that was developed for a California law to track each trade of drugs using serialization (scheduled to begin in 2015 but will be preempted by H.R. 3204 and blocked). The FDA should consider the models from many other countries that require tracking and serialization. This should be able to be accomplished in less than 2 years. Drug companies should be required to serialize drugs to comply with the March 2010, FDA guidance for serial numeric identifier (SNI) on drug products by 2016 (they were doing that to comply with California Law anyway). The drug companies should be required to track the change of custody of each drug item by 2017. This is important and patients are at risk now. Senators or either party seeking reelection will need to explain many things, adding H.R. 3204 weak prescription drug controls compared with other countries to explaining the shutdown and Affordable Care Act implementation may be more than their electorate will tolerate. Please – do not vote for H.R.3204 due to Title II. READ MORE FROM OTHERS AND SEE WHY WE ARE RIGHT: See what other countries are doing to track drugs: http://www.gs1.org/sites/default/files/docs/healthcare/13_GS1_HC_RefBook2013_All.pdf Industry is ready for unit serialization in life sciences: http://www.pharmaceuticalcommerce.com/index.php?pg=business_finance&articleid=26845&keyword=manufacturers-serialization-traceability Leading life sciences companies promised to be ready to provide serialized and tracked drug products in 2008. Why are we waiting so long? http://www.pharmacy.ca.gov/publications/ridleythomasletter.pdf Purdue Pharma: Learn how leading pharmaceutical manufacturer is combating counterfeiting and diversion of drugs in the healthcare supply chain with GS1 Standards. http://www.gs1us.org/Portals/0/gs1%20us%20library/case%20studies/Purdue%20Pharma%20-%20Improving%20Patient%20Safety%20and%20Supply%20Chain%20Efficiency.pdf EMD Serono: Learn how GS1 Standards-based solutions help a leading biopharmaceutical company to secure its global supply chain. http://www.gs1us.org/Portals/0/gs1%20us%20library/sectors/healthcare/industry%20use%20cases/EMD%20Serono%20Case%20Study.pdf McKinsey Healthcare Report: The McKinsey & Company report, Strength in unity: The promise of global standards in healthcare, estimates the benefits - in lives and value - of implementing one single global standard in healthcare. http://www.gs1.org/docs/healthcare/McKinsey_Healthcare_Report_Strength_in_Unity.pdf We have been discussing this topic in the US for many years. Why delay traceability by 10 more years? http://www.packworld.com/machinery/labeling/pedigree-paralysis-no-more