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Thursday, 09/04/2014 5:10:26 PM

Thursday, September 04, 2014 5:10:26 PM

Post# of 5055
A DRUG BY MERCK PHARMACUTICAL THAT WORKS LIKE TUBERCIN.....

After months of anticipation, the FDA has approved a new type of cancer drug that is designed to use the body’s own immune system to combat tumors and, in the process, may generate billions of dollars in sales. Known as Keytruda, the medicine is part of an anticipated wave of drugs that could transform cancer treatment and create a huge market for the pharmaceutical industry.

The drug will cost $12,500 a month and Merck says the median usage is 6.2 months, which works out to a $77,500 price tag, or $150,000 on annualized basis.

Keytruda is the first so-called PD-1 inhibitor to become available in the U.S. This type of drug blocks a protein called programmed death receptor 1, which acts as a brake on certain immune system cells and prevents them from attacking healthy tissue. Cancer cells can escape death by latching onto PD-1; the inhibitors block the interaction at the site of the tumor, releasing the brake that destroys the cancer.

The drug is intended for use following treatment with Yervoy, another immunotherapy treatment that works differently. The approval followed an accelerated review of clinical trial data from a relatively early-stage study. This was an unusual move, but it reflected intense interest in the medical community, which is excited, generally, about PD-1 inhibitors and the potential for combating other forms of cancer.

“PD-1 is truly a game change. It’s active in a way that other drugs are not,” Lynn Schuchter, a medical oncologist who heads the melanoma program at the Abramson Cancer Center at the University of Pennsylvania and who assisted in clinical trials for the Merck drug, tells The Wall Street Journal. “And what’s been interesting is the activity of PD-1 beyond melanoma. It looks to be active in bladder and renal and lung cancer.”

Indeed, physicians are optimistic about PD-1 drugs because they appear to induce relatively high rates of tumor shrinkage and prolong average survival beyond historical norms in clinical studies. And researchers say the side effects associated with the drugs appears to be manageable. Roche and Bristol-Myers Squibb BMY +0.04% are among the drug makers working to develop these medicines.

Some analysts believe total annual sales of all cancer immunotherapies could reach about $32 billion by 2025, assuming still more drugs are approved to treat difference cancers. Leerink analysts estimate that the new Merck drug alone could generate annual sales of more than $6 billion by then. Keytruda will cost $12,500 a month and the median length of use is estimated to be 6.2 months.

A competing PD-1 inhibitor was launched this month in Japan with a $143,000 price tag for a year’s treatment for the average patient. The drug, which is marketed by Ono Pharmaceutical and Bristol-Myers, is expected to be reviewed by the FDA in the next few months. Other PD-1 drugs are expected to cost a similar amount, which could fuel more debate about the affordability of new medicines.

According to the National Cancer Institute, an estimated 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease this year. Keytruda, by the way, is the sixth new melanoma treatment to be approved since 2011, although the FDA noted that drugs have different mechanisms of action.
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