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Weekly Drug News Round-Up: November 18, 2015

Darzalex Receives Accelerated Approval for Multiple Myeloma

Multiple myeloma is a blood cancer that occurs in infection-fighting white blood cells found in the bone marrow Read More...

This week FDA approved Janssen Biotech’s Darzalex (daratumumab), an injectable human anti-CD38 monoclonal antibody indicated to treat patients with multiple myeloma who have received at least three prior treatments including a proteasome inhibitor and an immunomodulatory agent. In clinical studies involving more than 140 people, Darzalex reduced the cancer's spread from 29 to 36 percent, according to FDA. Common side effects noted in studies included allergic-like reactions, fatigue, nausea, back pain, fever and cough. A reduction in white blood cells, as well as red blood cells and platelets were more serious side effects.

FDA Approves Adynovate Modified Antihemophilic Factor for Hemophilia A

Hemophilia A affects roughly one in every 5,000 male births in the United States Read More...

Adynovate (antihemophilic factor (recombinant) pegylated), a human antihemophilic factor indicated for the control and prevention of bleeding episodes in patients with hemophilia A, received FDA approval this past week. Hemophilia A is an inherited, sex-linked, blood-clotting disorder that is caused by defects found in the Factor VIII gene and primarily affects males. Bleeding occurs mainly in the joints. In clinical trials, when compared to standard therapy, Adynovate was effective in reducing the number of bleeding episodes during routine care. Additionally, Adynovate was effective in treating and controlling bleeding episodes. No safety issues were reported.

Tagrisso First Approved Agent for Specific Non-Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer affecting 90 percent of all patients Read More...

Lung cancer is the leading cause of cancer death in the U.S. FDA has approved Tagrisso (osimertinib), an oral tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR) indicated for the treatment of patients whose NSCLC tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy. In studies, 57 to 61 percent of patients experienced a complete or partial reduction in their tumor size. Side effects of Tagrisso are diarrhea, skin and nail conditions, inflammation of the lungs and injury to the heart. It also may cause harm to a developing fetus.

Gilead’s Harvoni Approved for Multiple Uses in HCV

Harvoni was first approved in 2014 for HCV genotype 1 Read More...

Harvoni (ledipasvir/sofosbuvir) contains a combination of ledipasvir and sofosbuvir, antiviral medications for treatment of chronic hepatitis C virus (HCV). FDA has approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection, in patients co-infected with HIV, and for use with ribavirin for 12 weeks (as an alternate therapy to 24 weeks of Harvoni) for treatment-experienced, genotype 1 patients with cirrhosis. Clinical studies show that sustained viral response at 12 weeks (SVR12, considered a cure) occurred in 93 to 97 percent of participants in these groups. In clinical studies, commonly reported side effects included asthenia, headache, cough and fatigue.

FDA Cracks Down of Makers of Toxic Nutritional Supplements

USPLabs defendants were arrested by U.S. Marshals on Tuesday Read More...

Buyer beware: the word “natural” on any bottle of dietary over-the-counter (OTC) nutritional supplement may be a lie. Yesterday, FDA announced a crackdown on 117 manufacturers or distributors of potentially dangerous dietary supplements often used for weight loss, body building and sexual enhancement. Products from USPLabs in Dallas, such as OxyElite Pro and Jack3d, contain a synthetic chemical known as aegeline linked to liver toxicity. The company continued to sell the dangerous supplement to unload the product, even after they were told to stop. Liver damage was so severe in some users that they required liver transplants, and one person died.

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