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FDA Approves Merck’s Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1

Posted 25 Sep 2017 by Drugs.com

KENILWORTH, N.J.--(BUSINESS WIRE) September 22, 2017 --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 treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. Continued approval for this indication may be conti ... Read more

Related support groups: Keytruda, Gastric Cancer, Pembrolizumab

FDA Medwatch Alert: Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold

Posted 1 Sep 2017 by Drugs.com

ISSUE: Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration today is issuing this statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma. The FDA statement is based on review of data from two clinical trials (KEYNOTE-183 and KEYNOTE-185) evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma. On July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with this drug, because interim results from both trials ... Read more

Related support groups: Multiple Myeloma, Keytruda, Pembrolizumab

Publicly Funded Cancer Trials Gained Americans 3 Million More Years

Posted 6 Jun 2017 by Drugs.com

TUESDAY, June 6, 2017 – Public-funded trials have significantly extended the lives of people diagnosed with cancer, according to new research. SWOG, the clinical trials network funded by the U.S. National Cancer Institute (NCI), has involved more than 200,000 patient volunteers. These trials have led to approval of 14 new cancer drugs and more than 100 changes to cancer care standards. All told, the clinical trials studied extended life by 3.34 million years, the study found. SWOG estimates the dollar return on investment from federal funding at $125 for each year of life gained. "A lot of people with cancer have lived longer because of the therapies tested in our publicly funded trials," study leader Joseph Unger said in a SWOG news release. He is an assistant member of the Fred Hutchinson Cancer Research Center's Cancer Prevention Program in Seattle. "At the same time, the cost of ... Read more

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

Experimental Gene-Targeted Drug Hits Cancer Where It Lives

Posted 4 Jun 2017 by Drugs.com

SATURDAY, June 3, 2017 – An experimental drug that targets a specific gene mutation can battle a range of advanced cancers in adults and children, researchers are reporting. The genetic abnormality is known as a TRK fusion, and it's found in only a small percentage of all cancers. So the drug, called larotrectinib, is no panacea. But researchers found that among 50 patients with TRK fusions, 76 percent saw their cancer regress after starting larotrectinib – regardless of their age or type of cancer. For most of those patients – 79 percent – the response has lasted at least one year, according to lead researcher Dr. David Hyman. "There are few therapies that have had that kind of success for patients like these," said Hyman, an oncologist at Memorial Sloan Kettering Cancer Center in New York City. Dr. William Oh, an oncologist who was not involved in the study, agreed. "A 76 percent ... Read more

Related support groups: Cancer, Breast Cancer, Lung Cancer, Colorectal Cancer, Keytruda, Head and Neck Cancer, Pembrolizumab, Salivary Gland Cancer

FDA Approves Keytruda (pembrolizumab) as First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature

Posted 25 May 2017 by Drugs.com

May 23, 2017 – The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs. “This is an important f ... Read more

Related support groups: Keytruda, Pembrolizumab, Solid Tumors

New Drug Approved for All Cancers With Genetic Marker

Posted 24 May 2017 by Drugs.com

TUESDAY, May 23, 2017 – Keytruda (pembrolizumab) has been approved by the U.S. Food and Drug Administration to treat any cancer that has a certain genetic biomarker, regardless of where in the body the cancer originated. "This is an important first for the cancer community," said Dr. Richard Pazdur, acting director of the agency's Office of Hematology and Oncology Products. "Until now, the FDA has approved cancer treatments based on where in the body the cancer started, for example lung or breast cancers. We have now approved a drug based on a tumor's biomarker without regard to the tumor's original location." The cancers targeted by this new drug have a genetic feature rendering them "microsatellite instability-high" (MSI-H) or "mismatch repair deficient" (dMMR), the agency explained Tuesday in a news release. MSI-H/dMMR tumors are most often found in colorectal, endometrial or ... Read more

Related support groups: Cancer, Keytruda

FDA OKs First Cancer Drug by Genetic Type, Not Organ of Origin

Posted 24 May 2017 by Drugs.com

WEDNESDAY, May 24, 2017 – Many new cancer drugs target genetic "biomarkers" that are specific to tumors – wherever in the body they may appear. So on Tuesday, the U.S. Food and Drug Administration announced that, for the first time, it had approved a cancer drug based on disease genetics rather than the body part where the cancer originated. The drug, Keytruda (pembrolizumab), is targeted to what are called "mismatch repair genes," and its approval means it can be used to fight tumors with these genes wherever they appear – in the colon, pancreas, stomach, ovaries or other body sites. "This is an important first for the cancer community," Dr. Richard Pazdur, acting 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. "Until now, the FDA has approved cancer treatments based on where in the body ... Read more

Related support groups: Cancer, Colorectal Cancer, Endometrial Cancer, Keytruda, Gastric Cancer, Diagnosis and Investigation

FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL)

Posted 15 Mar 2017 by Drugs.com

KENILWORTH, N.J. March 14, 2017 --(BUSINESS WIRE)--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 treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. Under the FDA’s accelerated approval regulations, this indication 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. In refractory or relapsed cHL, Keytruda is approved for use in adult patients at a fixed dose of 200 mg and in pediatric patients at a dose of 2 mg/kg (up to a maximum of 200 ... Read more

Related support groups: Lymphoma, Keytruda, Hodgkin's Lymphoma, Pembrolizumab

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, Keytruda, Opdivo, Melanoma - Metastatic, Nivolumab, Yervoy, Tecentriq, Pembrolizumab, Lemtrada, Campath, 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, Opdivo, Keytruda, Bladder Cancer, Melanoma - Metastatic, Head and Neck Cancer, Hodgkin's Lymphoma, Nivolumab, Tecentriq, 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, Keytruda, Head and Neck Cancer, 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, Depo-Provera, Provera, Methotrexate, Breast Cancer, Accutane, Lupron, Medroxyprogesterone, Tamoxifen, Arimidex, Tretinoin, Fluorouracil, Lupron Depot, Femara, Gleevec, Rituxan, Isotretinoin, Lung Cancer, Colorectal Cancer, Votrient

'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, Isotretinoin, Lung Cancer, Colorectal Cancer, Claravis, Tarceva, Xeloda, Skin Cancer, BCG, Tasigna, Revlimid, Sprycel, Herceptin, Hydroxyurea

Melanoma Drug Boosting Survival for Many, Study Shows

Posted 19 May 2016 by Drugs.com

THURSDAY, May 19, 2016 – A new drug for advanced melanoma is dramatically shifting the odds in favor of patients, extending survival for many and even curing some. Keytruda (pembrolizumab) helped keep four in 10 patients with advanced melanoma alive three years after starting treatment, according to the results of a new clinical trial. The drug also caused complete remission in 15 percent of patients, and many remained cancer-free even after they quit taking Keytruda, said Dr. Caroline Robert, head of the dermatology unit at the Institut Gustave-Roussy in Paris, France. Keytruda already has scored one very high-profile success – it's one of the drugs taken by former President Jimmy Carter, 91, in his successful battle last year against melanoma that had spread to his brain. However, the drug comes with a hefty price tag – an estimated $12,500 a month. Prior to the advent of targeted ... Read more

Related support groups: Melanoma, Skin Cancer, Keytruda, Melanoma - Metastatic, History - Skin Cancer

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