PHARMACY

FDA approves Bayer’s Nexavar for thyroid cancer

BY Alaric DeArment

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

The FDA announced the approval of Nexavar (sorafenib) to treat late-stage differentiated thyroid cancer. The drug was already approved for kidney and liver cancers. The drug works by limiting cancer cell growth and replication by inhibiting proteins within the cells.

"Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies," FDA Office of Hematology and Oncology Products Richard Pazdur said. "Today’s approval demonstrates the FDA’s commitment to expediting the availability of treatment options for patients with difficult-to-treat diseases."

 

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With Drug Quality and Security Act, federal government sticks its nose where it’s needed

BY Alaric DeArment

On Nov. 18, the Senate passed by voice vote the Drug Quality and Security Act, sending to president Barack Obama’s desk legislation that implements federal tracking and tracing of drugs and strengthens federal regulations on pharmacy compounding.

The bipartisan bill, which has the support of such trade groups as the National Association of Chain Drug Stores, the National Community Pharmacists Association and the Generic Pharmaceutical Association, ties up a couple of problematic loose ends in the pharmaceutical supply chain, namely the so-called "downstream" supply chain, which refers to the path that drugs take from their manufacturers to providers and patients, as well as sterile compounding.

The federal government already regulates the "upstream" supply chain – between manufacturers and their suppliers – but the downstream supply chain has long been regulated through a patchwork of state regulations that allows criminals to sneak counterfeit and adulterated drugs into the national supply chain through states with the laxest regulations. Without such inconsistencies, criminals will no longer find it easy to exploit the system.

The regulations concerning compounding pharmacies are important because they allow regulation of compounding of medicines for individual patients – which takes place at many pharmacies, including retail pharmacies – to continue happening at the state level, distinguishing it from large-scale sterile compounding of more complex medicines like injectables. In this way, the bill codifies the clear distinction between common pharmacy services and the kinds of activities that transform pharmacies into drug manufacturers.

In other words, the federal government is sticking its nose exactly where it needs to – in areas where patients’ safety has already been compromised on a large scale around the country and where risk has crossed state lines, sometimes with deadly consequences – and keeping it out of where state regulations are adequate.

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FDA gives regular approval to Pfizer’s Xalkori

BY Alaric DeArment

NEW YORK — The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.

Pfizer announced the approval of Xalkori (crizotinib) for anaplastic lymphoma kinase-positive non-small cell lung cancer that has spread to other parts of the body, as detected through testing. Lung cancer causes an estimated 1.4 million deaths around the world each year, according to the International Agency for Research on Cancer. According to Pfizer, more than 6,000 people globally have been treated with Xalkori, including those who received it in clinical trials, while Pfizer estimates that rates of testing for ALK in U.S. lung caner patients are more than 60%.

"Xalkori has dramatically changed the treatment landscape for patients with advanced ALK-positive NSCLC," Pfizer Oncology Business Unit president and general manager Garry Nicholson said. "Achievement of this milestone underscores Pfizer’s commitment to provide physicians with effective cancer therapies for their patients."

 

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