Skip to Content

Weekly Drug News Round-Up: April 13, 2016

Targeted Therapy Venclexta Granted FDA Approval for Rare Type of CLL

There are about 15,000 new cases of CLL diagnosed each year Read More...

In the fight against leukemia, the U.S. Food and Drug Administration (FDA) has approved AbbVie's Venclexta (venetoclax), an oral B-cell lymphoma-2 (BCL-2) inhibitor for chronic lymphocytic leukemia (CLL) with 17p deletion, a chromosomal abnormality detected with a FDA-approved diagnostic test. In patients, the CLL cancer cell growth is fed by the BCL-2 protein, but the new drug inhibits this protein. In a study, 106 patients took increasing doses of the Venclexta pill once a day for five weeks. Results showed that 80% of patients either saw improvement or their cancer fully disappear. Common side effects included low red and white blood cell count, diarrhea, nausea, and respiratory infections.

FDA Requires Label Changes to Metformin

The metformin label updates use in certain patients with kidney dysfunction Read More...

Metformin-containing medicines are available by prescription only and are used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes. From a review of studies, FDA has determined that metformin can be used safely in patients with mild kidney impairment and in some patients with moderate kidney impairment. Also, it is recommended that kidney function tests such as the glomerular filtration rate estimating equation (eGFR) be used instead of the blood creatinine concentration as the eGFR provides a better estimate of kidney function in patients with kidney disease. FDA is requiring these labeling changes updates be made for all metformin-containing medicines.

Expert Panel Backs Daily Aspirin to Ward Off Heart Disease, Colon Cancer

The panel still recommends a discussion with your doctor before starting aspirin Read More…

According to the U.S. Preventive Services Task Force (USPSTF), people 50- to 69-years old at increased risk for heart disease should be taking a daily, low-dose (81 milligram) aspirin to help prevent heart attacks, strokes, and colorectal cancer. However, the positive benefit is somewhat smaller for people in their 60s and the decision should be made in conjunction with a doctor based on the person’s risk factors. Plus, for those in their 50s, a daily aspirin may be appropriate only for those with low risk for stomach bleeding, who are expected to live 10 more years, and are willing to take a daily low-dose aspirin for at least 10 years.

Sun Pharma Receives FDA Approval For BromSite

BromSite is expected to be commercially available in the second half of 2016 Read More...

BromSite (bromfenac ophthalmic solution) 0.075% has been approved by the FDA for the treatment of postoperative inflammation and prevention of eye pain in patients undergoing cataract surgery. BromSite is formulated in a proprietary, polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies. In studies, significantly more patients treated with BromSite were pain-free the first day after surgery and inflammation-free 15 days after surgery compared to those who received only the product vehicle. Bromfenac is a nonsteroidal anti-inflammatory eye drop available in a generic, as well.

Prostate Cancer Treatment Linked to Depression

Overall, hormone therapy was tied to a 23 percent increase in the risk of depression Read More…

A large US Medicare study has found that hormone treatment of early-stage prostate cancer in older men may boost the risk for depression. Although the findings from the Medicare records do not definitively prove cause-and-effect, researchers reported in the Journal of Clinical Oncology that in roughly 78,000 U.S. men treated for prostate cancer between 1992 and 2006, 43 percent underwent hormone therapy. Of those who received hormones, 7 percent developed clinical depression. However, in men not receiving hormones, 5 percent were diagnosed with depression. Even accounting for factors that could lead to depression - such as cancer, age, or education - a link with was still seen.