It has been one of those weeks where each day I felt it was supposed to be the day after. Monday I thought was Tuesday, Tuesday, Wednesday and so on. Here at last, I think, is Friday – the real one. May your weekend go slowly and your Mondays with speed.
There were some interesting developments this week – here are a few:
- FDA Approves New Stomach Cancer Treatment – FDA announced approval of Lilly’s Cyramza (ramucirumab) – another approval under FDA’s priority review program and an orphan drug designation – for the treatment of advanced stomach cancer. The treatment is an angiogenesis inhibitor that acts by blocking the blood supply to tumors and is intended for patients were surgery cannot remove the cancer or which has spread after treatment with a fluoropyrimidine or platinum contianing therapy. The company put out a multi-media release on the approval with a good deal of clinical trial detail. Cyramza has a Boxed Warning for increased risk of hemorrhage, including severe and sometimes fatal events.
- Expedited Program Proposed for Medical Devices – The agency announced this week that it was proposing a new program that would provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose needs are unmet by existing technology. The program will feature earlier involvement with FDA staff and a collaboratively developed plan for collecting the necessary data for approval. The agency stressed that the Expedited Access PMA or “EAP” is not a new pathway to market, but a new approach to facilitate development under the existing framework.
- FDA Say E-nuff Regarding Lack of E-Cigarette Regulation – It was only a matter of time, and many wonder what took so long, but this week FDA unveiled a proposal that would extend tobacco regulating authority that is in place over many products such as cigars, pipe tobacco, water pipes and other means of delivery for nicotine including the e-cigarette. The goal was stated as making the next generation tobacco-free. The regulation would bring all of these products and apply the same rules that are now applied to tobacco with respect to new product development and marketing. A full court communications press was staged by FDA including provision of the proposed rule for comment, a blog posting from the Commissioner, a consumer update and a web page on the topic.
- First Test for HPV Approved – Another landmark first from the agency this week when it was announced that the first human papillomavirus (HPV) test was approved for use. Approved for women 25 and older, the release states that the test will serve as an indicator for physicians and patients to screen a patient to assess the need to undergo additional diagnostic testing for cervical cancer. The approval is an expansion upon an earlier indication for the test whereby it was used in conjunction with a Pap test.
That’s it for me this week. Fairly sure that it is Friday today, I wish you a good weekend.
