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Weekly Drug News Round Up - December 10, 2014

Gardasil 9 Approved to Treat 5 More Types of HPV

Gardasil 9 is approved for use in females ages 9 to 26 and males ages 9 to 15 Read More...

Today, the U.S. Food and Drug Administration approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of diseases caused by nine types of Human Papillomavirus (HPV), five more types than Gardasil (previously approved by the FDA). Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers. Gardasil 9 adds protection against these five additional HPV types - 31, 33, 45, 52 and 58 - which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.

Incyte’s Jakafi Approved for Chronic Bone Marrow Disease

Jakafi is the first FDA-approved treatment for polycythemia vera Read More...

Polycythemia vera is a type of bone marrow disease where too many red blood cells, white blood cells, and platelets may occur. Too many blood cells can cause the spleen to swell, lead to bleeding and possibly an increased risk of stroke or heart attack. In response, the U.S. Food and Drug Administration (FDA) has approved Jakafi (ruxolitinib), an oral kinase inhibitor. In clinical trials, 21 percent of Jakafi-treated participants had lower rates of phlebotomy and increased spleen volume, compared to 1 percent of participants who received best available therapy. Jakafi was originally approved in 2011 to treat myelofibrosis.

Amgen’s Xgeva Wins Added Use for Hypercalcemia of Malignancy

HCM is a serious complication that suggests a poor prognosis in patients with advanced cancer Read More…

The U.S. Food and Drug Administration (FDA) has approved a new indication for Xgeva (denosumab) for hypercalcemia of malignancy (HCM) without adequate response to bisphosphonate therapy. Xgeva is a monoclonal antibody that binds to RANK Ligand (RANKL) and modulates calcium release from bone. In clinical trials, the primary endpoint was defined as albumin-corrected serum calcium <11.5 mg/dL within 10 days after the first dose of Xgeva. The study achieved its primary endpoint with a response rate at day 10 of 63.6 percent in the 33 patients evaluated. The median duration of response was 104 days.

Painkiller Tramadol May Lead to Low Blood Sugar: Study

The hypoglycemia can occur in any patient - not just diabetics Read More...

Tramadol (Ultram) is an oral narcotic-like analgesic and is approved for the treatment of pain in adults. Tramdol use has increased steadily in the U.S due to a perceived safer risk profile and tighter controls on other painkillers. A new, but early, study in JAMA Internal Medicine points to a risk of low blood sugar (hypoglycemia) with its use. The new research links the drug to around a 3-fold increased risk of being hospitalized for hypoglycemia. However, the overall risk was still quite low, occurring in less than one person for every 1,000 people taking the drug every year. Learn more about tramadol here.

Breast Cancer Vaccine Shows Promise in Advanced Disease

Minimal side effects included rash, tenderness and mild flu-like symptoms Read More...

Early results in a small study looking at an experimental vaccine for breast cancer are encouraging. The vaccine was designed to stop breast cancer in its tracks. Fourteen women with metastatic (spreading) breast cancer were injected with a vaccine that targets a protein found in about 80 percent of breast cancers known as mammaglobin-A. The vaccine prompts a specific kind of white blood cell in the immune system to find mammaglobin-A and eliminate it. Although the study was small, at one year, roughly 50 percent of the patients with advanced disease showed no sign of disease progression, compared to 20 percent in a similar group.