PHARMACY

Onco360 added to limited-distribution network for J&J, Pharmacyclics blood cancer drug

BY Alaric DeArment

NEW YORK — Johnson & Johnson and Pharmacyclics have added a New York-based specialty pharmacy company focused on cancer to their limited-distribution network for a drug recently approved for a rare form of blood cancer.

Onco360 said Wednesday that it had become part of the network for distributing Imbruvica (ibrutinib) capsules. The announcement came the same day that the Food and Drug Adminsitration announced the approval of Imbruvica (ibrutinib) for mantle cell lymphoma, or MCL.

"As one of the select few specialty pharmacies in the network, Onco360 is very proud to have been chosen by Pharmacyclics and Janssen Biotech," Onco360 CEO Burt Zweigenhaft said, referring to the J&J subsidiary that co-markets Imbruvica.

Limited-distribution networks are set up by drug companies in order to control the distribution of drugs, usually specialty drugs that are distributed only to a few select specialty pharmacies. While their purpose is to ensure more efficient production, distribution and use of the drugs, they also often exclude retail pharmacies.

 

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FDA approves Imbruvica for mantle cell lymphoma

BY Alaric DeArment

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

BY Alaric DeArment

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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