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PD-1 Inhibitors - new type of cancer drug are approved
 
 
  "FDA Approves Merck's PD-1 Inhibitor, Keytruda......Bristol-Myers Squibb received approval in Japan for their anti-PD-1 drug, Opdivo (nivolumab), leading to speculation that it might be the first to be approved in the U.S.....is expected to be reviewed by U.S. regulators in coming months.......http://www.forbes.com/sites/davidkroll/2014/09/04/mercks-keytruda-surprise-winner-in-u-s-pd-1-inhibitor-race/........KEYTRUDA is the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States and received FDA's Breakthrough Therapy designation for advanced melanoma......http://www.mercknewsroom.com/news-release/oncology-newsroom/merck-receives-accelerated-approval-keytruda-pembrolizumab-first-fda-......based on the significance of early study findings and the unmet medical need. For the recommended 2 mg/kg dose based on data in 89 patients, the overall response rate was 24 percent (95% CI: 15, 34), with one complete response and 20 partial responses (21/89). At the time of analysis, 86 percent (18/21) of patients with objective responses had ongoing responses with durations ranging from 1.4+ to 8.5+ months, including eight patients with ongoing responses of 6 months or longer. Fourteen percent (3/21) had progression of disease 2.8, 2.9, and 8.2 months after initial response."
 
"About 76,000 Americans are diagnosed with melanoma each year, and about 9,700 die of the disease annually, according to the American Cancer Society.......http://online.wsj.com/articles/fda-approves-mercks-cancer-drug-1409856320.......Pembrolizumab is the first so-called PD-1 inhibitor to hit the U.S. market. The drugs block a protein called programmed death receptor 1, or PD-1, which acts as a brake on certain immune-system cells to prevent them from attacking healthy tissue. Cancer cells can escape destruction by latching onto PD-1; PD-1 inhibitors block this interaction at the site of the tumor, releasing the immune system brake and allowing it to destroy the cancer......."Now I have patients coming back in significant numbers who are effectively treated with this agent, and the response is durable," said Antoni Ribas, a melanoma specialist and professor of medicine at UCLA's David Geffen School of Medicine, who served as lead investigator of the study........Still, the Merck drug and other immunotherapies don't work in every patient and can't be considered a broad-based cure........Patient interest in the Merck drug and other immunotherapies has given rise to petition drives and social-media campaigns seeking access to the drugs before regulators had approved them for sale. Such demand has fueled legislation in some states that gives terminally ill patients a "right to try" certain experimental drugs without having to go through an FDA program for early access, if a drug's manufacturer is willing. Merck started an early access program for pembrolizumab in March, but restricted it to patients whose disease had progressed after treatment with Yervoy and, if applicable, a drug targeting a genetic mutation known as BRAF.....Merck Chief Executive Kenneth C. Frazier, a company veteran since 1992, called pembrolizumab "one of the most exciting programs I've been associated with since I've been at Merck." He likened it to the company's introduction of anti-HIV medicine Crixivan in 1996, among the early protease inhibitors that helped reduce the risk of death from AIDS"
 
"The first of a promising new class of cancer drugs went on sale in Japan this week.....treatment for unresectable melanoma, a deadly form of skin cancer......The drug Opdivo from Ono Pharmaceuticals & Bristol-Myers Squibb Co. .......Opdivo-whose generic name is nivolumab-in Japan as a treatment for unresectable melanoma, a deadly form of skin cancer.......Doctors and drug makers say PD-1 inhibitors represent a significant advance in cancer treatment-particularly in melanoma-because they have produced relatively high rates of tumor shrinkage and patient survival in clinical studies......Melanoma patients who received nivolumab in one clinical trial had a median overall survival of nearly 17 months. About 62% of patients receiving the drug were still alive one year after starting treatment, while 43% were still alive at two years......PD-1 drugs "have the potential to be game-changers for a lot of people" because patients in studies have had "meaningful, long-term responses" to the drugs. PD-1 targeting drugs have shown strong cancer-fighting results in clinical trials.......Although the study didn't directly compare nivolumab-treated patients with those who didn't receive nivolumab, the survival rates compare favorably with historical norms for older treatments. Until a few years ago, patients with melanoma that had spread to other parts of the body could be expected to live for less than a year, on average.......PD-1 inhibitors have shown potential to improve treatment for other types of tumors, including lung and bladder cancers. Bristol also has reported relatively high rates of tumor shrinkage and survival for a combination of Yervoy and nivolumab in clinical testing..... Sovaldi and the newer hepatitis-C treatments can cure many patients of infection in 12 weeks, studies have shown, preventing it from worsening to diseases like liver cancer.......Merck.....PD-1 inhibitor, pembrolizumab......FDA decision on pembrolizumab for melanoma is due by Oct. 28, but could come sooner, possibly within days, according to people familiar with the matter......CVS Health said the company is unlikely to see a big cost impact from the PD-1-targeting drugs until 2015 or 2016, as more hit the market and their use widens to multiple cancer types. CVS typically plans ahead to try to ensure new drugs are used in a "cost-effective manner," he said.
 
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Powerful New Cancer Drugs Offer Hope-at Steep Cost
 
High Cost for Drug in Japan Is Signal of Hefty Prices Expected in U.S., Europe

 
http://online.wsj.com/articles/powerful-new-cancer-drugs-offer-hopeat-steep-cost-1409788867
 
The first of a promising new class of cancer drugs went on sale in Japan this week at an average annual cost of $143,000 a patient, a harbinger of hefty prices the new drugs are expected to command in the U.S. and Europe in coming months.
 
The drug Opdivo, from Ono Pharmaceutical Co. 4528.TO +0.22% and Bristol-Myers Squibb Co......is a so-called PD-1 inhibitor, a new type of drug that harnesses the body's immune system to fight tumors, including melanoma. Several other pharmaceutical companies are also developing PD-1 targeting drugs.
 
High prices for the treatments come as concerns mount about the affordability of new drugs. Debate about pricing reached a peak this year with the launch of an expensive new drug for hepatitis C.
 
Government health officials, private insurers and some members of Congress expressed concern that the $84,000-per-patient drug-Sovaldi from Gilead Sciences Inc. GILD -2.35% -was straining health budgets. Some prisons and state Medicaid programs said they couldn't afford to give the drug to every patient who qualified for it medically. Gilead said the drug has a high cure rate and can stave off more costly health interventions if the disease is left untreated.
 
More new drugs with the potential to carry high prices are on the horizon. The U.S. Food and Drug Administrationhas approved Merck MRK -0.66% & Co.'s PD-1 inhibitor, pembrolizumab, for sale to treat melanoma, while newer hepatitis-C drugs from Gilead and AbbVie Inc. ABBV +0.05% may hit the U.S. market by the end of this year.
 
Some of the new drugs have brought real medical advances for diseases that long confounded researchers. Sovaldi and the newer hepatitis-C treatments can cure many patients of infection in 12 weeks, studies have shown, preventing it from worsening to diseases like liver cancer. Doctors say metastatic melanoma is being transformed from a disease with a dismal outlook for most patients to one where many may live longer because of the new drugs.
 
J. Leonard Lichtenfeld, deputy chief medical officer for the American Cancer Society, said higher prices for new cancer drugs have become an increasing concern for patients and their families, who often shoulder high copayments. At the same time, the PD-1 drugs "have the potential to be game-changers for a lot of people" because patients in studies have had "meaningful, long-term responses" to the drugs. PD-1 targeting drugs have shown strong cancer-fighting results in clinical trials.
 
Ono is marketing Opdivo-whose generic name is nivolumab-in Japan as a treatment for unresectable melanoma, a deadly form of skin cancer.
 
Bristol-Myers, which plans to market nivolumab in the U.S. if the FDA clears it for sale, declined to say how much it will charge. A spokeswoman said the company prices its medicines based on "the value they deliver to patients and society, the scientific innovation they represent and the investment required to support" drug research-and-development.
 
Prices for patented, brand-name drugs in Japan are typically at least 18% lower than in the U.S., according to the U.S. Department of Commerce. Japan imposes price cuts every two years, while manufacturers are free to raise prices in the U.S.
 
Osaka-based Ono Pharmaceutical received Japanese regulatory approval in July. The company disclosed the Japanese price for the drug on Tuesday, when it formally went on sale.
 
New York-based Bristol-Myers plans to apply by Sept. 30 for U.S. regulatory approval to market nivolumab as a treatment for melanoma, and expects to complete by year-end an application for U.S. clearance to market the drug to treat a form of lung cancer.
 
Bristol-Myers has been marketing another kind of cancer immunotherapy, Yervoy, as a melanoma treatment in the U.S. since 2011 at a cost of $120,000 a patient for a standard, complete course of treatment.
 
Doctors and drug makers say PD-1 inhibitors represent a significant advance in cancer treatment-particularly in melanoma-because they have produced relatively high rates of tumor shrinkage and patient survival in clinical studies.
 
Melanoma patients who received nivolumab in one clinical trial had a median overall survival of nearly 17 months. About 62% of patients receiving the drug were still alive one year after starting treatment, while 43% were still alive at two years.
 
Although the study didn't directly compare nivolumab-treated patients with those who didn't receive nivolumab, the survival rates compare favorably with historical norms for older treatments. Until a few years ago, patients with melanoma that had spread to other parts of the body could be expected to live for less than a year, on average.
 
PD-1 inhibitors have shown potential to improve treatment for other types of tumors, including lung and bladder cancers. Bristol also has reported relatively high rates of tumor shrinkage and survival for a combination of Yervoy and nivolumab in clinical testing.
 
The Japanese price tag stems from Ono's negotiations with that country's National Health Insurance system, which sets introductory prices for new drugs. Ono said the price negotiated with Japan's national health insurance program is 729,849 for a 100-milligram vial of nivolumab. The drug is infused intravenously every three weeks at a dose that is based on a patient's weight. Using the average Japanese patient weight of 132 pounds, the annual cost would come to 15 million, Ono said. That translates into about $143,000 a year at recent exchange rates.
 
Some U.S. pharmaceutical analysts have estimated the anti-PD-1 drugs would cost more than $100,000 a patient a year. A standard duration of treatment hasn't yet been established, but some patients in clinical studies have received them indefinitely as long as they were doing well.
 
Merck has declined to say how much it plans to charge for its PD-1 inhibitor drug, pembrolizumab. A U.S. FDA decision on pembrolizumab for melanoma is due by Oct. 28, but could come sooner, possibly within days, according to people familiar with the matter.
 
Troyen Brennan, chief medical officer of pharmacy-services provider CVS Health, CVS -0.06% said the company is unlikely to see a big cost impact from the PD-1-targeting drugs until 2015 or 2016, as more hit the market and their use widens to multiple cancer types. CVS typically plans ahead to try to ensure new drugs are used in a "cost-effective manner," he said.

 
 
 
 
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