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Related terms: Cancer, Malignant Plasmacytoma, Cancer, Multiple Myeloma, Cancer, Plasma Cell Dyscrasia, Cancer, Plasma Cell Myeloma, Malignant Plasmacytoma, Myeloma, Multiple, Plasma Cell Dyscrasia, Plasma Cell Myeloma, Plasmacytoma of Bone

Darzalex (daratumumab) Approved by FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy

Posted 15 days ago by Drugs.com

HORSHAM, PA, Nov. 21, 2016 – Janssen Biotech, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved Darzalex (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.1 Clinical studies have shown that Darzalex, in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, reduced the risk of disease progression or death by 63 percent, compared to lenalidomide and dexamethasone alone, in patients with multiple myeloma who received a median of one prior therapy (Hazard Ratio [HR]=0.37; 95 percent CI [0.27, 0.52], p Read more

Related support groups: Dexamethasone, Multiple Myeloma, Bortezomib, Lenalidomide, Daratumumab, Darzalex

Drug Trio Shows Major Promise Against Myeloma

Posted 6 Oct 2016 by Drugs.com

THURSDAY, Oct. 6, 2016 – Adding a newer drug to a standard treatment for advanced cases of multiple myeloma may significantly boost patients' chances of a response and even recovery, a new clinical trial finds. Of patients given the drug, called daratumumab, 43 percent had a complete response – meaning there were no signs of the cancer left. That compared with 19 percent of patients who received a standard drug duo alone. And over 13.5 months, the daratumumab combination cut patients' risk of dying or seeing their cancer progress by 63 percent, the study found. Researchers called the results "unprecedented" for patients like these. All had relapsed or refractory myeloma – which means the cancer had either come back or failed to respond to the previous treatment. "It is very likely that (this regimen) will be rapidly adopted by practicing physicians," said lead researcher Dr. Meletios ... Read more

Related support groups: Dexamethasone, Decadron, Multiple Myeloma, Revlimid, TobraDex, Ciprodex, Maxitrol, Ozurdex, Osteolytic Bone Lesions of Multiple Myeloma, Tobradex ST, Dexamethasone/Neomycin/Polymyxin B, Lenalidomide, Decadron Tablets, Dexamethasone/Tobramycin, Adrenocot, Maxidex, Decadron Dose Pack, Dexone, Poly-Dex, Adrenocot LA

Superior Results for Myeloma Drug That's Added Earlier in Treatment

Posted 6 Jun 2016 by Drugs.com

MONDAY, June 6, 2016 – A recently approved immunotherapy drug for a blood cancer called multiple myeloma can provide even better benefits if patients receive it earlier in their treatment, new clinical trial results show. Darzalex (daratumumab) reduced patients' risk of cancer progression by 70 percent when added to a standard two-drug regimen for people with recurring myeloma, said lead researcher Dr. Antonio Palumbo. He is chief of the myeloma unit at the University of Torino department of oncology in Italy. The new drug essentially doubled the response that doctors expect from the standard regimen of bortezomib (another immunotherapy drug) and dexamethasone (a steroid drug). About 19 percent of patients given Darzalex had their cancer go into full remission, compared with just 9 percent of those taking the standard treatment, researchers found. "Very good" response rates doubled to ... Read more

Related support groups: Multiple Myeloma, Osteolytic Bone Lesions of Multiple Myeloma, Daratumumab, Darzalex

Exercise May Cut Risk of 13 Cancers, Study Suggests

Posted 16 May 2016 by Drugs.com

MONDAY, May 16, 2016 – Exercise may significantly reduce your risk for many types of cancer, including some of the most lethal forms of the disease, a large review suggests. Working out for even a couple of hours a week appears to shrink the risk of breast, colon and lung cancer, said researchers who looked at 1.4 million adults. "Those are three of the four major cancers that affect Americans today," said Marilie Gammon. She is a professor of epidemiology with the University of North Carolina at Chapel Hill Gillings School of Public Health. And fitness buffs, take heart – your cancer risk appears to continue to decline as you rack up hours of physical activity, with no apparent upper plateau, said study lead author Steven Moore, an investigator with the U.S. National Cancer Institute. "The more activity, the more the benefit," Moore said. "As people did more, their risk continued to ... Read more

Related support groups: Cancer, Breast Cancer, Leukemia, Lung Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer, Multiple Myeloma, Endometrial Cancer, Small Cell Lung Cancer, Bladder Cancer, Acute Myeloid Leukemia, Stomach Cancer, Head and Neck Cancer, Breast Cancer, Prevention, Acute Lymphoblastic Leukemia, Gastric Cancer, Osteolytic Bone Lesions of Multiple Myeloma, Urinary Tract Cancer, Acute Myeloblastic Leukemia

FDA Medwatch Alert: BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries

Posted 16 May 2016 by Drugs.com

ISSUE: FDA is informing health care professionals that a counterfeit version of the FDA approved cancer drug, BiCNU (carmustine for injection) 100 mg, has been detected in some foreign countries. There is no indication at this time that counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received counterfeit BiCNU. See the FDA Alert for more information, including product photos and affected lot numbers. BACKGROUND: The authentic product is approved to treat different types of brain cancer, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s). BiCNU is manufactured by Emcure Pharmaceuticals Ltd. and distributed in the United States by Heritage Pharmaceuticals Inc. BiCNU is available as a vial of BiCNU and dehydrated alcohol co-packaged together. While the NDC on the outer package of the authentic and counterfeit ver ... Read more

Related support groups: Brain Tumor, Multiple Myeloma, Non-Hodgkin's Lymphoma, Glioblastoma Multiforme, Hodgkin's Lymphoma, Malignant Glioma, BiCNU

Radon in the Home May Be Linked to Blood Cancers in Women

Posted 3 May 2016 by Drugs.com

TUESDAY, May 3, 2016 – New research suggests a strong link between exposure to high levels of radon in the home and women's risk of blood cancers. Radon is a naturally occurring radioactive gas, the U.S. Environmental Protection Agency says. It's known to cause lung cancer and is the second leading cause of lung cancer in the United States, the researchers said. The American Cancer Society collected information over 19 years on more than 140,000 Americans as part of a prevention study. During that time, just over 3,000 cases of blood cancer were diagnosed. The cancers included leukemia, lymphoma and myeloma, the study found. Women who lived in counties with the highest radon levels were 63 percent more likely to develop blood cancers than those in counties with the lowest radon levels. There was no link seen among men, the study noted. The study was published online recently in the ... Read more

Related support groups: Cancer, Leukemia, Lung Cancer, Lymphoma, Non-Small Cell Lung Cancer, Poisoning, Multiple Myeloma, Small Cell Lung Cancer, Toxic Reactions Incl Drug and Substance Abuse

FDA Grants Spectrum Pharmaceuticals Approval of Evomela (melphalan) for Injection

Posted 16 Mar 2016 by Drugs.com

HENDERSON, Nev., March 15, 2016 --(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted approval of Evomela for use in two indications: 1) use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma (MM), and 2) for the palliative treatment of patients with MM for whom oral therapy is not appropriate. This is the first product to be FDA-approved for the high-dose conditioning indication in MM. “I am very proud to announce that Spectrum has been able to bring another new cancer drug to the market,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pha ... Read more

Related support groups: Multiple Myeloma, Melphalan, Evomela

FDA Approves New Kyprolis (Carfilzomib) Combination Therapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Posted 21 Jan 2016 by Drugs.com

THOUSAND OAKS, Calif., Jan. 21, 2016 /PRNewswire/ – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent. "Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a ... Read more

Related support groups: Multiple Myeloma, Carfilzomib, Kyprolis

Empliciti Approved for Multiple Myeloma

Posted 1 Dec 2015 by Drugs.com

MONDAY, Nov. 30, 2015 – Empliciti (elotuzumab), in combination with two other drugs, has been approved by the U.S. Food and Drug Administration to treat the blood cancer multiple myeloma. The drug is only approved for patients who have already been given one-to-three prior therapies for the disease. Multiple myeloma is a type of cancer that affects germ-fighting white blood cells produced in bone marrow. Symptoms typically include a weakened immune system and bone and kidney problems. Nearly 27,000 new cases are projected in the United States, and more than 11,000 will die from it this year, the National Cancer Institute estimates. Empliciti directs the immune system to kill multiple myeloma cells, the FDA explained Monday in a news release. It is approved in combination with another anti-cancer drug, Revlimid (lenalidomide), and the corticosteroid dexamethasone. Empliciti was ... Read more

Related support groups: Multiple Myeloma, Empliciti, Elotuzumab

FDA Approves Empliciti (elotuzumab) for Multiple Myeloma

Posted 1 Dec 2015 by Drugs.com

November 30, 2015 – Today the U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. This disease may result in a weakened immune system, and cause other bone and kidney problems. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year. “We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma," said Richard P ... Read more

Related support groups: Multiple Myeloma, Empliciti, Elotuzumab

Ninlaro Approved for Multiple Myeloma

Posted 20 Nov 2015 by Drugs.com

FRIDAY, Nov. 20, 2015 – Ninlaro (ixazomib), in combination with two other drugs, has been approved by the U.S. Food and Drug Administration to treat people with multiple myeloma who have had at least one prior treatment with a different therapy. Multiple myeloma is a type of cancer that forms in infection-fighting white blood cells produced in bone marrow. Symptoms include a weakened immune system and bone and kidney problems. Ninlaro, from a class of drugs called proteasome inhibitors, is designed to block enzymes that spur the growth and survival of multiple myeloma cells, the FDA said Friday in a news release. Almost 27,000 cases of multiple myeloma will be diagnosed in the United States this year, and more than 11,000 people are projected to die from it, the FDA said, citing the National Cancer Institute. Ninlaro is approved in combination with another multiple myeloma drug, ... Read more

Related support groups: Multiple Myeloma, Ninlaro, Ixazomib

FDA Approves Ninlaro (ixazomib) for Multiple Myeloma

Posted 20 Nov 2015 by Drugs.com

November 20, 2015 – Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. The disease may result in a weakened immune system and cause other bone or kidney problems. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year. “As we learn more about the underlying biology of multiple myeloma, we are encouraged to see the development of new ways to treat this disease,” said Richard Pa ... Read more

Related support groups: Multiple Myeloma, Ninlaro, Ixazomib

Darzalex Approved for Multiple Myeloma

Posted 16 Nov 2015 by Drugs.com

MONDAY, Nov. 16, 2015 – The injected chemotherapy drug Darzalex (daratumumab) has been approved by the U.S. Food and Drug Administration to treat people who have had at least three prior treatments for multiple myeloma, a form of blood cancer. The disease affects germ-fighting white blood cells found in bone marrow, potentially causing a weakened immune system, and problems involving the bones and kidneys. It's expected to be diagnosed in nearly 27,000 people and cause more than 11,000 deaths in the United States this year, the FDA said, citing estimates from the U.S. National Cancer Institute. Darzalex is a monoclonal antibody that's designed to help the body's immune system fight cancer cells, the FDA said. In clinical studies involving more than 140 people, Darzalex reduced the cancer's spread by 29 percent to 36 percent, the agency said. The drug's most common side effects included ... Read more

Related support groups: Multiple Myeloma, Darzalex, Daratumumab

FDA Approves Darzalex (daratumumab) for Patients with Previously Treated Multiple Myeloma

Posted 16 Nov 2015 by Drugs.com

November 16, 2015 – Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. The disease may result in a weakened immune system and cause other bone or kidney problems. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year. “Targeting proteins that are found on the surface of cancer cells has led to the development of i ... Read more

Related support groups: Multiple Myeloma, Darzalex, Daratumumab

Research Spots Link Between Agent Orange, Blood Cancer in Vietnam Vets

Posted 3 Sep 2015 by Drugs.com

THURSDAY, Sept. 3, 2015 – Vietnam veterans exposed to Agent Orange have a more than doubled risk of developing abnormal blood cells that can become cancerous, a new study suggests. The researchers found that U.S. Air Force vets who conducted aerial herbicide spray missions of Agent Orange during the Vietnam War had a 2.4 times increased risk of developing the blood disease known as monoclonal gammopathy of undetermined significance (MGUS). The presence of MGUS in a person's blood is a prerequisite for developing multiple myeloma, explained lead author Dr. Ola Landgren, a hematologist-oncologist and chief of the myeloma service at Memorial Sloan Kettering Cancer Center in New York City. "Most people who have MGUS will not develop multiple myeloma, but everyone who has myeloma first had MGUS," Landgren said. About 30 percent of people with MGUS will develop multiple myeloma within 30 ... Read more

Related support groups: Cancer, Multiple Myeloma

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