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Weekly Drug News Round-Up: December 21, 2016

Rubraca Gets Early Accelerated Approval for Ovarian Cancer

Roughly 15 to 20 percent of patients with ovarian cancer have a BRCA gene mutation Read More...

In an end-of-year approval, the U.S. Food and Drug Administration (FDA) has cleared Clovis Oncology's Rubraca (rucaparib), over two months early, for the treatment of advanced mutant BRCA ovarian cancer. Rubraca is approved for women who have been treated with two or more chemotherapies and whose tumors have a specific BRCA gene mutation. Rubraca, a poly (ADP-ribose) polymerase (PARP) inhibitor, blocks an enzyme involved in repairing damaged DNA inside the cancerous cells containing the damaged BRCA genes. In studies, 54% of patients who received Rubraca experienced complete or partial shrinkage of their tumors lasting a median of 9.2 months. Common side effects of Rubraca include nausea, fatigue, and vomiting among other reactions.

Tresiba Now Approved for Pediatric Patients with Type 1 and 2 Diabetes

Tresiba is the only basal insulin approved for both type 1 and type 2 diabetes in patients as young as 1 year old Read More...

This week, the FDA expanded the age of the population approved to use Novo Nordisk’s Tresiba (insulin degludec injection 100 U/mL, 200 U/mL). Patients from one year of age through adulthood can now use this once-daily, long-acting basal insulin for blood sugar control in both type 1 and type 2 diabetes. In non-inferiority studies in children 1 to 17 years of age with type 1 diabetes, Tresiba was compared to Levemir (insulin detemir [rDNA origin] injection), with both study groups using insulin aspart at mealtime. Studies showed effective blood sugar control with the most common adverse events being infection, hypoglycemia and hyperglycemia.

FDA Alert: Chantix and Zyban Label Revised

FDA determines the benefits of quitting smoking outweigh the risks of these medicines Read More...

Based on post-marketing studies, the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) has been found to be lower than previously suspected. These risks are still present, especially with mental illness; however, the consequences were not serious for most patients. Based on these studies, FDA will remove the Boxed Warning from Chantix and remove the associated language in the Zyban Boxed Warning. A patient Medication Guide will still be given with each prescription, but the risk evaluation and mitigation strategy (REMS) will be removed.

Prostate Cancer Therapy from Ocean Linked With Fewer Side Effects

Fiber optic lasers inserted into the prostate activate the drug to kill the cancer without harming the prostate Read More...

In a new study published in The Lancet Oncology, an investigational treatment for prostate cancer is being called “transformative”. Normally, when men are treated for prostate cancer with surgery or radiation, urinary incontinence and sexual difficulties can occur. However, the new therapy combines laser light with ocean bacteria that can kill the cancer when exposed to light. In 413 men, almost half had no remaining cancer after undergoing treatment. Plus, only six percent of the men had to undergo prostate removal, compared with 30 percent who did not have the new therapy. According to researchers, sexual and urination problems lasted no longer than three months among patients who had the new therapy.

Over-the-Counter Pain Drugs May Affect Hearing in Women

The study doesn't yet establish a cause-and-effect relationship

In a study published in the American Journal of Epidemiology, women using the common pain relievers ibuprofen (Advil, Motrin) or acetaminophen (Tylenol) for six years or longer were at greater risk of hearing loss than if they used the drugs for one year or less. Researchers analyzed data from more than 54,000 primarily white women ages 48 to 73 from the Nurses' Health Study. Researchers state that assuming causality, roughly 16 percent of hearing loss in these women could be due to ibuprofen or acetaminophen use. The overall magnitude of risk could be substantial given the fact that these pain drugs are widely used throughout the U.S.