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Bristol-Myers Squibb’s Opdivo (nivolumab) is the First Immuno-Oncology Treatment to Receive FDA Approval Based on Overall Survival in Head and Neck Cancer

Posted 14 Nov 2016 by Drugs.com

PRINCETON, N.J.--(BUSINESS WIRE) November 10, 2016 --Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.1 Opdivo is the first and only Immuno-Oncology treatment proven in a Phase 3 trial to significantly extend overall survival (OS) for these patients.1 In oncology clinical trials, OS is considered the gold standard primary endpoint to evaluate the outcome of any therapy.3 The approval was based on results from the Phase 3, CheckMate -141 trial in which Opdivo demonstrated statistically significant and clinically meaningful superior OS vs the comparator arm (investigator’s choice of methotrexate, d ... Read more

Related support groups: Opdivo, Head and Neck Cancer, Nivolumab

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, Alemtuzumab, Ipilimumab, Atezolizumab

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

Arthritis Possible Side Effect of Certain Cancer Drugs: Study

Posted 29 Jun 2016 by Drugs.com

TUESDAY, June 28, 2016 – Certain cancer immunotherapy drugs may increase risk for joint and tissue disease, including arthritis, new research suggests. "We keep having referrals coming in from our oncologists as more patients are treated with these drugs," said Dr. Clifton Bingham, director of the Johns Hopkins Arthritis Center in Baltimore. "In particular, as more patients are treated with combinations of multiple immunotherapies, we expect the rate to go up," he said in a Hopkins news release. Drugs like ipilimumab and nivolumab are called checkpoint inhibitor drugs. Between 2012 and 2016, 13 patients given these drugs at Johns Hopkins Kimmel Cancer Center (1.3 percent of the total using them) developed new-onset arthritis, or autoimmune disorders that cause dry eyes and mouth, the researchers said. However, further research is needed to confirm a cause-and-effect relationship, the ... Read more

Related support groups: Rheumatoid Arthritis, Cancer, Osteoarthritis, Juvenile Rheumatoid Arthritis, Opdivo, Yervoy, Nivolumab, Ipilimumab

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, Lupron Depot, Femara, 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

Opdivo (nivolumab) FDA Approved for the Treatment of Hodgkin Lymphoma

Posted 18 May 2016 by Drugs.com

PRINCETON, N.J., May 17, 2016 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.1 This accelerated approval is based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This first approval of a PD-1 inhibitor for cHL patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is based on a combined analysis of data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 trials.1 Based on this analysis (n=95), Opdivo ... Read more

Related support groups: Opdivo, Hodgkin's Lymphoma, Nivolumab

Drug Seems to Extend Survival for Advanced Melanoma Patients

Posted 18 Apr 2016 by Drugs.com

MONDAY, April 18, 2016 – More than one-third of advanced melanoma patients were still alive five years after starting therapy with the cancer drug nivolumab (Opdivo), researchers are reporting. "In 2012, we saw some very promising early evidence that this drug could not only cause the regression of very advanced cancer in patients with melanoma, lung or kidney cancers that had not responded to other forms of therapy, but we also saw that these responses appeared to be very durable," said lead researcher Dr. Suzanne Topalian. She is a professor of surgery and oncology at Johns Hopkins University School of Medicine, in Baltimore. Opdivo was approved for the treatment of advanced melanoma by the U.S. Food and Drug Administration in 2014. The results of this follow-up study, funded by Bristol-Myers Squibb, which makes Opdivo, were to be presented Sunday at the American Association for ... Read more

Related support groups: Lung Cancer, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Melanoma, Small Cell Lung Cancer, Melanoma - Metastatic, Opdivo, Nivolumab, Wilms' Tumor

Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status

Posted 24 Jan 2016 by Drugs.com

PRINCETON, N.J., January 23, 2016 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.1 This indication is approved under accelerated approval based on progression-free survival (PFS).1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1 This approval expands the original indication for the Opdivo + Yervoy Regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial, in which PFS and overall ... Read more

Related support groups: Melanoma, Melanoma - Metastatic, Opdivo, Yervoy, Nivolumab, Ipilimumab

FDA Approves Opdivo to Treat Metastatic Renal Cell Carcinoma

Posted 23 Nov 2015 by Drugs.com

November 23, 2015 – The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. “Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease.” Torisel (temsirolimus), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer. Renal cell carcinoma is the most common form of kidney cancer in adults and forms in the tissues of the kidney that make urine. The National Cancer Institute estimates 61,560 ... Read more

Related support groups: Renal Cell Carcinoma, Opdivo, Nivolumab

FDA Expands Approved Use of Opdivo (nivolumab) in Advanced Lung Cancer

Posted 9 Oct 2015 by Drugs.com

October 9, 2015 – The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy. 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. The most common type of lung cancer, non-small cell lung cancer (NSCLC), is further divided into two main types named for the kinds of cells found in the cancer – squamous cell and non-squamous cell (which includes adenocarcinoma).Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Opdivo may help the body’s immune system fight the cancer cells. Earlier this year, the FDA approved Opdivo to treat patients with advan ... Read more

Related support groups: Non-Small Cell Lung Cancer, Opdivo, Nivolumab

BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma

Posted 1 Oct 2015 by Drugs.com

PRINCETON, N.J., October 1, 2015 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.1 Today’s announcement marks the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer. This indication is approved under accelerated approval based on tumor response rate and durability of response.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1 The approval is based on data from the pivotal study, CheckMate -069, which was the first to report outcomes of the Opdivo + Yervoy Regimen in previously untreated patients with unresectable or metastatic melanoma. R ... Read more

Related support groups: Melanoma, Melanoma - Metastatic, Opdivo, Yervoy, Nivolumab, Ipilimumab

New Drug May Boost Survival a Bit for Some With Advanced Lung Cancer

Posted 28 Sep 2015 by Drugs.com

SUNDAY, Sept. 27, 2015 – A new study finds that the cancer drug nivolumab (Opdivo) extends the lives of some patients with advanced lung cancer for several months. In a head-to-head comparison, patients treated with nivolumab lived an average of 12.2 months, while patients treated with the chemotherapy drug docetaxel lived an average of 9.4 months, the researchers reported. "It looks like we have a new treatment option for patients with metastatic lung cancer that progresses after standard chemotherapy," said lead researcher Dr. Hossein Borghaei, chief of thoracic medical oncology at Fox Chase Cancer Center in Philadelphia. "Now we have another tool, but we have to learn how to make it better so people can even live longer," he said. The results of this phase 3 trial, which was funded by nivolumab's maker Bristol-Myers Squibb, were to be presented Sunday at the European Cancer Congress ... Read more

Related support groups: Lung Cancer, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Taxotere, Opdivo, Nivolumab, Docetaxel, Docefrez, Bronchogenic Carcinoma

New Immune-Focused Drug Shows Promise Against Advanced Kidney Cancer

Posted 25 Sep 2015 by Drugs.com

FRIDAY, Sept. 25, 2015 – A new drug that harnesses the power of the immune system to fight tumors appears to help people battling advanced kidney cancer, a new study finds. The drug, Opdivo (nivolumab), outperformed a standard chemotherapy, Afinitor (everolimus), in terms of shrinking tumors and boosting patient survival, the study found. The study was funded by Bristol-Myers Squibb, which makes Opdivo. It was to be presented Friday at the European Cancer Congress in Vienna, and is being published simultaneously in the New England Journal of Medicine. The new findings "are significant and clinically meaningful to patients and health care professionals alike," senior researcher Dr. Padmanee Sharma, of the University of Texas M.D. Anderson Cancer Center in Houston, said in a meeting news release. Sharma, a professor in the departments of genitourinary medical oncology and immunology, ... Read more

Related support groups: Renal Cell Carcinoma, Afinitor, Opdivo, Wilms' Tumor

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, Femara, Lupron Depot, Gleevec, Lung Cancer, Renal Cell Carcinoma, Colorectal Cancer, Isotretinoin

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Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma - Metastatic, Hodgkin's Lymphoma, Melanoma, Head and Neck Cancer

Opdivo Patient Information at Drugs.com