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Weekly Drug News Round-Up: September 7, 2016

FDA Approves Amgen’s Blincyto For New Pediatric Indication

ALL is one of the most common types of cancer in children Read More...

The U.S. Food and Drug Administration (FDA) has approved Amgen’s Blincyto (blinatumomab) for the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ALL is a cancer of a specific type of white blood cell called lymphocytes. Blincyto, an immunotherapy, acts as a connector between a protein called CD19, which is found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes. Under an accelerated approval plan, Blincyto was evaluated in 93 pediatric patients with relapsed or refractory B-cell precursor ALL in Phase 1 and 2 studies. Long-term efficacy is currently being monitored.

Arzerra Now Approved For Combination CLL Treatment

CLL chronic lymphocytic leukemia is a slowly progressing cancer of the blood and bone marrow Read More...

Chronic lymphocytic leukemia (CLL) is the most commonly diagnosed adult leukemia in Western countries, and accounts for approximately 1 in 4 cases of leukemia. This past week, the FDA approved Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). In an open label, Phase III study which included 365 patients, the primary endpoint was met in patients receiving ofatumumab in combination with FC. A median progression free survival of 28.9 months occurred in combination group with Arzerra, compared to 18.8 months in patients receiving FC alone.

FDA Bans 19 Chemicals in Antibacterial Soaps Used by Consumers

Manufacturers must re-label, reformulate or remove them from store shelves Read More...

Plain old soap and water seems to be safer and just as effective in killing germs as the popular antibacterial soaps used by millions of consumers, according to the FDA. Last week the FDA banned 19 chemicals in antibacterial soaps, including triclosan and triclocarban, the two most common antibacterial ingredients. The FDA is worried that antibacterial soaps might be contributing to bacterial resistance with antibiotics. Plus, there is concern that triclosan can affect the thyroid, estrogen and testosterone systems of mammals. The new ban does not cover hand sanitizer gels or wipes, which usually contain alcohol, or antiseptics used in the healthcare setting.

Birth Control Pills Linked to Lower Ovarian Cancer Death Rates

The study was not designed to prove cause-and-effect, but researchers say the association is there Read More...

A recent study published in the Annals of Oncology suggests that the use of birth control pills around the world have had an impact on lowered rates of ovarian cancer death. For example, analysis of World Health Organization data found that the ovarian cancer death rate fell 16 percent in the United States and almost 8 percent in Canada between 2002 and 2012. Denmark and Sweden each saw a drop of 24 percent in their death rate from ovarian cancer, the researchers said. Other factors may include reduced use of hormone replacement therapy in menopause and better diagnosis and treatment of ovarian cancer.

FluMist Nasal Vaccine Should Not Be Used This Year

Flu shots are now available in many clinics and pharmacies in the U.S. Read More...

The American Academy of Pediatrics (AAP) has released a statement that the nasal spray FluMist  (influenza virus vaccine) should not be used for influenza prevention in the 2016-2017 flu season. These recommendations align with the CDC, too. FluMist was at one time the preferred flu vaccine for pediatric patients; however, recent studies show a lack of effectiveness. The nasal spray vaccine's effectiveness among children aged 2 to 17 was just 3 percent in 2015-16, compared with 63 percent for the injected vaccine, according to the infectious disease experts. All children aged 6 months and older should receive a seasonal flu shot during the 2016-17 flu season.