FDA actions

FDA actions

A new selective estrogen receptor modulator (SERM) has been approved for the treatment of dyspareunia due to vulvar and vaginal atrophy in postmenopausal women. Ospemifene appears to benefit vaginal epithelium without significant effect on the endometrium. The drug’s safety and efficacy was established in three clinical trials of nearly 1900 postmenopausal women with vulvar and vaginal atrophy who were randomly assigned to ospemifene or placebo. After 12 weeks, the first two trials showed statistically significant improvement in dyspareunia while the third trial supported the long-term safety of the drug. The drug is contraindicated in women with genital bleeding, estrogen-dependent cancer, or thromboembolic disease. The risk of stroke and VTE was higher than baseline but lower than the rates seen with estrogen replacement therapy. Ospemifene comes with a boxed warning regarding endometrial hyperplasia and abnormal vaginal bleeding. Common side effects include hot flashes, vaginal discharge, muscle spasms, and sweating. It will be marketed by Shionogi Inc. as Osphena.

The FDA has approved ado-trastuzumab emtansine for use as a single agent in patients with late-stage, HER2-positive breast cancer. The drug is approved for patients who have already been treated with trastuzumab and taxane separately or in combination. Approval was based on a study of nearly 1000 women with metastatic breast cancer in which progression-free survival was about 3 months longer with the drug compared to lapatinib plus capecitabine, and overall survival was about 6 months longer. Ado-trastuzumab emtansine is marketed by Genentech as Kadcyla.