Weekly Roundup 10.30.15

If you are like me, you have raided – at least once – the stash of candy you have squirreled away to give out this weekend. It happens every year. I am weak. Fortunately, tomorrow they will arrive and take the tempting morsels away.

I had intended on some postings this week between the Weekly Roundup, but time simply did not permit. I will try harder next week. In the meantime, here is a bit of what happened.

  • Novel New Approval in Melanoma – It was announced this week that FDA had approved Imlygic™ (talimogene laherparepvec) for the treatment of melanoma lesions in the skin and lymph nodes which cannot be removed completely with surgery. The treatment is the first FDA-approved oncolytic virus therapy. The therapy is injected directly into melanoma lesions where it replicates inside cancer cells and causes their death. The company noted in its press release that the therapy has not been shown to improve overall survival or have an effect on visceral metastases.
  • Second Melanoma Development – In addition to the above novel treatment, FDA also announced the expanded approval of Yervoy (ipilimumab) for its inclusion as an adjuvant therapy for patients with stage III melanoma to lower the risk of recurrence of the condition following surgery. Yervoy, a monoclonal antibody, was originally approved in 2011 to treat late-stage melanoma. Yervoy blocks a particular molecule that may play a role in slowing down the body’s immune system and therefore affecting the ability to fight off cancerous cells. In clinical studies, 49 percent of participants who were administered Yervoy saw their cancer return after an average of 26 months compared to 62 percent of those who received placebo who saw their cancer return on average in seventeen months. The label includes a Boxed Warning and it will be accompanied by a Medication Guide. The company press release can be seen here.
  • Polling Public Outlook on FDA Review of Drug Ads – This week the Kaiser Family Foundation released a poll on a number of aspects of prescription drugs – involving issues ranging from pricing to advertising. On the latter, the poll found that a majority of people – in fact 90 percent – felt that FDA should review prescription drug ads before they air. According to the KHN story (“Majority of American Agree That The FDA Should Review Drug Ads Before They Air“, by Shefali Luthra, October 28, 2015). The piece has some very interesting data on how many viewers of such ads then act on the information to talk to their doctor and the results of that interaction.

That’s it for me this week folks. Have a fun and safe Halloween and enjoy the weekend.

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