[blair77]

New therapies - timelines, what can we do?

by blair77 on Thu Feb 13, 2014 11:20 pm

I am curious as to any information about when drugs like elotuzumab and daratumumab (spelling) are hoping to be approved?

I am also wondering if their are any ways that patients could advocate for faster approval.

[Multibilly]

Re: New therapies - timelines, what can we do?

by Multibilly on Fri Feb 14, 2014 8:34 am

Daratumumab has been fast tracked for approval by the FDA by being classified as a "breakthrough" treatment for heavily pretreated multiple myeloma patients. I don't believe any other multiple myeloma MABs in development have received this designation, but I'm not positive.

Based on this article, there is speculation that maybe it might get approved by mid-2015?

http://www.orf-blog.com/is-genmabs-daratumumab-the-next-ibrutinib/

[Nancy Shamanna]

Re: New therapies - timelines, what can we do?

by Nancy Shamanna on Fri Feb 14, 2014 9:54 am

Hi! On the topic of drug approvals, I think that one way in which patients and caregivers can help with 'fast tracking' approvals is to be on the mailing lists of the support groups, both locally and nationally and internationally. I am sure that the questionnaire put out by the IMF and Myeloma Canada asking about people's experiences with pomalidomide, was really helpful in getting the drug approved by Health Canada. Apparently there were hundreds of replies to that questionnaire, and it all helps when regulators are trying to sift and sort through literally hundreds of applications for drug approvals. If you get notice of a questionnaire and can fill it out and send it in, it all helps. i think that carfilzomib was 'fast tracked' in the US, and there was a lot of patient input on that (I even wrote the FDA a letter, although I am not an American. I said that the drug could go world wide to help patients, eventually!).

Another way to help to get new drugs is to read up on all the latest treatments. I have found the Beacon's scientific articles, which are written with the average reader in mind, to be very helpful in trying to understand how successful various drugs are in treating myeloma. Also, if you read the abstracts referenced in the articles, you will see many of the famous myeloma researchers as investigators too. If we keep up with what the new trends are in research, we may be able to help better as advocates for new drugs too! At least we can write letters when we need to!