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Genmab Announces U.S. FDA Approval of Darzalex (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

Posted 1 day 6 hours ago by Drugs.com

Copenhagen, Denmark; June 16, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today the U.S. Food and Drug Administration (FDA) has approved the use of Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Darzalex is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize the product. Genmab will receive milestone payments totaling USD 25 million from Janssen in connection with the approval and first commercial sale of Darzalex under the newly expanded label. The sale is expected to occur quickly after the approval. The approval and related milestones do not impact the financial guidance issued by G ... Read more

Related support groups: Multiple Myeloma, Darzalex, Daratumumab

Publicly Funded Cancer Trials Gained Americans 3 Million More Years

Posted 16 days ago 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, Prostate Cancer, Medroxyprogesterone, Tamoxifen, Arimidex, Fluorouracil, Tretinoin, Lupron Depot, Femara, Colorectal Cancer, Gleevec, Rituxan, Lung Cancer, Isotretinoin

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 23 Nov 2016 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, Darzalex, Daratumumab

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, Dexamethasone/Tobramycin, Osteolytic Bone Lesions of Multiple Myeloma, Ozurdex, Decadron Tablets, Tobradex ST, Dexamethasone/Neomycin/Polymyxin B, Maxidex, Lenalidomide, Darzalex, Decadron Dose Pack, Dexone, Poly-Dex, Neo-Poly-Dex

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, Darzalex, Daratumumab

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, Colorectal Cancer, Gleevec, Rituxan, Lung Cancer, Isotretinoin, Votrient

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

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Multiple Myeloma

Darzalex Patient Information at Drugs.com