It has been way too long since a Weekly Roundup and way too long since a regular posting. The autumn has turned out to be an exceptionally busy time so apologies on both fronts. But today I’m carving out a little time to at least get out a Roundup and hopefully will have a few new postings next week regarding some things on my mind.
In the meantime, we are getting up in darkness and switching out our closets from summer wear to autumnal clothing. Upstate New York has seen some snow. In the mid-Atlantic, we have had some chilly mornings. And on Monday we will hand out candy to costumed little ones counting on our answering the doorbell. In the meantime, here is a bit of what has transpired at FDA:
- Male Hormones, Female Sex-drive and Guidance – A couple of things on this front. This week FDA issued class-wide labeling changes for testosterone and other anabolic steroids to include expanded warnings, stating a possible association with abuse and dependence and citing specific potential among adults and adolescents engaged in body building and warning of a number of adverse associations. Also this week, the agency issued guidance entitled “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment” to assist sponsors in what has been an often elusive category in the development of treatments for women. The guidance provides overall thinking toward a clinical trials, with specific focus on Phase III trial designs.
- Accelerated Approval for Soft Tissue Carcinoma Treatment – A new treatment – Lartruvo – with breakthrough therapy status, priority review and fast track designation won accelerated approval this week for the treatment of certain types of soft tissue carcinoma (STS). In the FDA release, Lartruvo is described as a platelet-derived growth factor receptor-alpha blocking antibody which may help slow or stop tumor growth by blocking receptors that cause growth. Lartruvo also has orphan drug status, with the National Cancer Institute estimating that 12,310 new cases and 5,000 deaths will occur in 2016. Lartruvo is approved for use with chemotherapy in STS for patients who cannot be cured with radiation or surgery and who have a type of STS for which chemotherapy is an appropriate treatment. You can read the company press release here.
- First Line Treatment for Immunotherapy in NSCLC – Keytruda, a compound under study for multiple types of cancer, received FDA approval as a first-line treatment of metastatic non-small cell lung cancer in patients who have a high PD-L1 expression over 50 percent. The approval was granted after studies showed improved survival time over chemotherapy. The company press release can be found here.
That’s it for me this week. Have a great weekend everyone.