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Pembrolizumab News

Powerful Cancer Drugs Linked to Rare Heart Risks

Posted 3 Nov 2016 by Drugs.com

THURSDAY, Nov. 3, 2016 – In rare cases, potent drugs that prompt the immune system to fight cancer may threaten the heart in the process, researchers report. Known as immunotherapy, these medications have transformed cancer treatment in recent years, sending some patients who had few options left into remission. But a report in the Nov. 3 issue of New England Journal of Medicine describes two cases where patients with advanced melanoma died of heart trouble two weeks after receiving their first doses of Opdivo (nivolumab) and Yervoy (ipilimumab). One patient was a 65-year-old woman who died following a rapid heartbeat and organ failure, while the other patient was a 63-year-old man who died after two rounds of sudden cardiac arrest. With a heart attack, blood flow to the heart is blocked and tissue damage occurs, while in the case of sudden cardiac arrest the heart suddenly stops ... Read more

Related support groups: Cancer, Breast Cancer, Colorectal Cancer, Melanoma, Melanoma - Metastatic, Opdivo, Keytruda, Tecentriq, Yervoy, Nivolumab, Pembrolizumab, Campath, Lemtrada, Ipilimumab, Alemtuzumab, Atezolizumab

FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Certain Patients with Metastatic Non-Small Cell Lung Cancer

Posted 25 Oct 2016 by Drugs.com

KENILWORTH, N.J.--(BUSINESS WIRE) October 24, 2016 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. With this new indication, Keytruda is now the only anti-PD-1 therapy to be approved in the first-line treatment setting for these patients. In addition, the FDA approved a labeling update to include data from KEYNOTE-010 in the second-line or greater treatment setting for patients with metastatic NSCLC whose tumors express PD-L1 (TPS of ... Read more

Related support groups: Lung Cancer, Non-Small Cell Lung Cancer, Keytruda, Pembrolizumab

More Cancer Patients Gaining From Immune-Based Treatments

Posted 20 Sep 2016 by Drugs.com

TUESDAY, Sept. 20, 2016 – A leading cancer group says more Americans are benefiting from immunotherapy – a relatively new treatment approach that helps the immune system target and destroy cancer cells. "The promise of immunotherapy for cancer therapy has never been greater, and the opportunity to make significant progress in this critical area is real," said Dr. Nancy Davidson, president of the American Association for Cancer Research (AACR). The AACR issued the news on immunotherapy as part of its 2016 Cancer Progress Report. As the group explained, more types of cancer are being successfully treated with immunotherapy. This treatment involves adding new cancer-fighting cells to the body or adding new elements, such as antibodies and proteins, to help the immune system fight cancer. In August 2015, one class of immunotherapy drugs – called checkpoint inhibitors – was approved for ... Read more

Related support groups: Lung Cancer, Non-Small Cell Lung Cancer, Melanoma, Bladder Cancer, Melanoma - Metastatic, Opdivo, Head and Neck Cancer, Keytruda, Hodgkin's Lymphoma, Tecentriq, Nivolumab, Pembrolizumab, Atezolizumab

FDA Approves Merck’s Keytruda (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Posted 8 Aug 2016 by Drugs.com

KENILWORTH, N.J.--(BUSINESS WIRE)--August 5, 2016 Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Under the FDA’s accelerated approval regulations, this indication for Keytruda is approved based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. For HNSCC patients, PD-L1 testing is not needed prior to use of Keytruda. The approval is based on data ... Read more

Related support groups: Cancer, Head and Neck Cancer, Keytruda, Pembrolizumab

U.S. Pays Highest Prices for Cancer Meds: Study

Posted 6 Jun 2016 by Drugs.com

MONDAY, June 6, 2016 – The United States pays the highest prices in the world for generic and brand-name cancer drugs, a new study has found. However, as the world's wealthiest nation, the United States is better able to pay for those pricey drugs than poorer countries with somewhat lower medication prices, added study lead author Dr. Daniel Goldstein. People in China and India are much less able to afford cancer drugs than Americans, he said, even though U.S. monthly drug prices are about three to six times higher in the United States. That doesn't mean America came out on top in overall drug affordability, however. Developed nations such as Australia, England and Israel had the "best deal" in the world on cancer drugs, thanks to government programs that regulate drug pricing, the study found. "America is the wealthiest nation, but its drug prices are significantly higher – so much ... Read more

Related support groups: Cancer, Provera, Depo-Provera, Methotrexate, Breast Cancer, Accutane, Lupron, Tamoxifen, Medroxyprogesterone, Arimidex, Tretinoin, Fluorouracil, Femara, Lupron Depot, Gleevec, Lung Cancer, Colorectal Cancer, Rituxan, Isotretinoin, Claravis

'Precision' Cancer Treatment May Extend Lives

Posted 20 May 2016 by Drugs.com

THURSDAY, May 19, 2016 – "Precision" cancer treatment that's guided by genetic clues from the patient's own tumor appears to outperform traditional chemotherapy, a new research review finds. Patients given precision – or personalized – treatment experienced a tumor shrinkage rate six times that attained by regular chemotherapy. But, that only happened if doctors used genetic information to choose the appropriate targeted therapy, said lead researcher Maria Schwaederle. Those patients also experienced nearly double the length of time before their cancer resumed growing, according to the analysis of nearly 350 clinical trials. "It is not just that the therapies are better, but that targeted therapies must be given to the right patients," said Schwaederle, who's with the University of California, San Diego School of Medicine's Center for Personalized Cancer Therapy. She will present ... Read more

Related support groups: Cancer, Methotrexate, Breast Cancer, Accutane, Tretinoin, Fluorouracil, Gleevec, Lung Cancer, Colorectal Cancer, Isotretinoin, Claravis, Tarceva, Xeloda, Skin Cancer, BCG, Revlimid, Tasigna, Hydroxyurea, Sprycel, Zytiga

FDA Approves Expanded Indication for Keytruda (pembrolizumab) for the Treatment of Patients with Advanced Melanoma

Posted 23 Dec 2015 by Drugs.com

KENILWORTH, N.J.--(BUSINESS WIRE) December 18, 2015 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. This approval marks the second FDA-approved indication in advanced melanoma for Keytruda, which is now the first anti-PD-1 therapy approved for previously untreated advanced melanoma patients regardless of BRAF status. The FDA-approved dose of Keytruda is 2 mg/kg every three weeks. In a Phase 3 trial, KEYNOTE-006, patients with unresectable or metastatic melanoma who were treated with Keytruda experienced superior overall survival (OS) compared to those treated with ipilimumab. In this s ... Read more

Related support groups: Melanoma, Melanoma - Metastatic, Keytruda, Pembrolizumab

Keytruda Approved for Leading Form of Lung Cancer

Posted 2 Oct 2015 by Drugs.com

FRIDAY, Oct. 2, 2015 – Keytruda (pembrolizumab) has been approved by the U.S. Food and Drug Administration to treat advanced cases of the most common type of lung malignancy, non-small cell lung cancer (NSCLC). The drug is approved for people whose tumors produce a protein called PD-L1, and whose cancer has lingered despite use of other treatments, the agency said Friday in a news release. Lung cancer is the most common cause of cancer death in the United States, accounting for more than 220,000 cases and more than 158,000 deaths so far this year, the FDA said. Keytruda, in blocking the PD-L1 protein, helps the body better fight this cancer, the FDA explained. The drug was first approved in 2014 to treat advanced melanoma skin cancer. Keytruda's performance in fighting lung cancer was evaluated in clinical studies of 550 people with advanced disease. The most common side effects ... Read more

Related support groups: Lung Cancer, Non-Small Cell Lung Cancer, Keytruda, Pembrolizumab

FDA Approves New Treatment for Lung Cancer

Posted 2 Oct 2015 by Drugs.com

FRIDAY, Oct. 2, 2015 – The U.S. Food and Drug Administration on Friday approved an immunotherapy drug for the treatment of advanced non-small cell lung cancer. Keytruda (pembrolizumab) can be used to treat advanced non-small cell lung cancer in patients whose disease has progressed after previous treatments and who have tumors that express a protein called PD-L1, the agency said. "Today's approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. The Merck & Co. drug was approved for use with a companion diagnostic test that is the first designed to detect PD-L1 expression in non-small cell lung tumors, the FDA said in the news release. By blocking what ... Read more

Related support groups: Lung Cancer, Non-Small Cell Lung Cancer, Keytruda, Pembrolizumab

FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer

Posted 2 Oct 2015 by Drugs.com

October 2, 2015 – The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors. Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. NSCLC is the most common type of lung cancer.“Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine,” said Richard Pazdur, M.D., director o ... Read more

Related support groups: Lung Cancer, Non-Small Cell Lung Cancer, Keytruda, Pembrolizumab

Jimmy Carter Being Treated for Melanoma That Has Spread to Brain

Posted 20 Aug 2015 by Drugs.com

THURSDAY, Aug. 20, 2015 – Displaying the grace and calm that has been a hallmark of much of his public life, former President Jimmy Carter announced Thursday that doctors have found cancer on his brain, and he plans to undergo radiation treatment and targeted therapy. An MRI scan has revealed four spots of melanoma on Carter's brain, the 90-year-old Georgia native said during a press conference at The Carter Center in Atlanta. "They are very small spots, about 2 millimeters, if you can envision what a millimeter is. I get my first radiation treatment for the melanoma in my brain this afternoon," Carter said. He will undergo four treatments at three-week intervals. Carter also will receive treatments of pembrolizumab (Keytruda), an intravenous drug that boosts the body's immune response against melanoma cells. The former president said he's already been given the drug once, for 30 ... Read more

Related support groups: Melanoma, Melanoma - Metastatic, Keytruda, Pembrolizumab

U.S. Oncologists Decry High Cost of Cancer Drugs

Posted 23 Jul 2015 by Drugs.com

THURSDAY, July 23, 2015 – Soaring costs for cancer drugs are hurting patient care in the United States, a group of top oncologists claim. "High cancer-drug prices are affecting the care of patients with cancer and our health care system," Dr. Ayalew Tefferi, a hematologist at Mayo Clinic in Rochester, Minn., said in a Mayo news release. Tefferi and his colleagues made a number of recommendations on how to address the problem in a commentary published July 23 in the Mayo Clinic Proceedings. Allowing Medicare to negotiate drug prices is one of the suggestions the team of 118 leading cancer experts offered as a possible solution. Along with their recommendations, the group also expressed support for a patient-based grassroots movement on change.org that is demanding action on the issue. "The average gross household income in the U.S. is about $52,000 per year. For an insured patient with ... Read more

Related support groups: Cancer, Provera, Depo-Provera, Methotrexate, Breast Cancer, Accutane, Lupron, Prostate Cancer, Tamoxifen, Medroxyprogesterone, Arimidex, Tretinoin, Fluorouracil, Lupron Depot, Femara, Gleevec, Lung Cancer, Renal Cell Carcinoma, Colorectal Cancer, Isotretinoin

Gene Test May Predict Success of Cancer Drug in Certain Patients

Posted 29 May 2015 by Drugs.com

FRIDAY, May 29, 2015 – The first genetic "marker" – or signal – to predict response to the cancer drug Keytruda (pembrolizumab) has been identified by researchers. The marker – mismatch repair (MMR) deficiency – predicted responses to the drug in patients with several different types of cancer, the study authors said. Among patients with colon cancer, 62 percent of those with MMR-deficient tumors showed tumor shrinkage when taking Keytruda, compared with no tumor shrinkage in patients without this genetic signal. The response rate among patients with other MMR-deficient cancers was 60 percent, according to the study. "This study is really about bridging immunotherapy and genomics for the benefit of patients, and it has implications for a broad range of cancers," study lead author Dr. Dung Le said in a news release from the American Society of Clinical Oncology (ASCO). Le is an ... Read more

Related support groups: Cancer, Colorectal Cancer, Keytruda, Diagnosis and Investigation, Pembrolizumab

Too Few Prostate Cancer Patients Get Bone-Strengthening Meds: Study

Posted 3 Dec 2014 by Drugs.com

TUESDAY, Dec. 2, 2014 – Many men on hormone therapy for prostate cancer aren't getting bone-strengthening drugs they may need, new Canadian research contends. Hormone therapy, which suppresses male hormones called androgens, helps stop cancer cells from growing. But one consequence of the treatment is weakening of the bones, which can lead to fractures. To reduce this risk, men can be given oral bisphosphonates, such as Fosamax, or an intravenous treatment once a month or once a year with similar drugs, such as Reclast. "There seems to be a clear mismatch between Canadian guidelines regarding bisphosphonate usage in men undergoing hormone therapy for prostate cancer and actual clinical practice," said lead researcher Dr. Shabbir Alibhai, a senior scientist at the University Health Network in Toronto. While the low rates of bisphosphonate prescriptions may be appropriate for patients ... Read more

Related support groups: Provera, Depo-Provera, Accutane, Lupron, Prostate Cancer, Tamoxifen, Medroxyprogesterone, Fosamax, Arimidex, Tretinoin, Femara, Lupron Depot, Boniva, Isotretinoin, Alendronate, Claravis, Anastrozole, Reclast, Evista, Zoladex

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