[Beacon Staff]

Elotuzumab receives Breakthrough Therapy designation

by Beacon Staff on Mon May 19, 2014 8:58 am

The companies developing elotuzumab as a potential new therapy for multiple myeloma have announced that the drug has received "Breakthrough Therapy" designation from the U.S. Food & Drug Administration.

You can view the press release from the companies about this development here:

https://myelomabeacon.org/pr/2014/05/19/elotuzumab-breakthrough-therapy-designation-fda/

You can also view all the Beacon's news articles re: elotuzumab here:

https://myelomabeacon.org/tag/elotuzumab/

Finally, as many of you may know, Beacon columnist Arnold Goodman is currently being treated with elotuzumab through "compassionate use" access to the drug. He writes about this a bit in his most recent column, which you can view here:

https://myelomabeacon.org/headline/2014/05/13/arnies-rebounding-world-n-of-1/

[Multibilly]

Re: Elotuzumab receives Breakthrough Therapy designation

by Multibilly on Mon May 19, 2014 10:09 pm

This is great and welcome news.

Beacon Staff: Based on your experience with other multiple myeloma drugs that have received this designation, how far off would you guess we are from seeing this drug approved by the FDA?

[Beacon Staff]

Re: Elotuzumab receives Breakthrough Therapy designation

by Beacon Staff on Mon May 19, 2014 10:16 pm

Hi Multibilly,

Thanks for your posting. It reminded us that we forgot to add an update to this thread noting that we published our own article on the news a bit later after our initial posting to start the thread.

Here is a link to our news article about the breakthrough therapy designation:

Elotuzumab Receives Breakthrough Therapy Designation For Multiple Myeloma

As we mention in the article, the current expectations are that elotuzumab could be approved in the U.S. by the middle of next year -- probably sometime in the second quarter.

This is a projection, subject to all the usual uncertainties. But it's the best guess at this time, and we suspect it's also a fairly good guess.

We're still working on projections for a European launch and will update our article and this forum thread once we have any news on that front.

[Beacon Staff]

Re: Elotuzumab receives Breakthrough Therapy designation

by Beacon Staff on Wed May 21, 2014 2:29 pm

Just a quick update ... We have done some additional research to firm up the projected approval date for elotuzumab in the U.S. After discussions with some financial analysts, we have revised our projection, and we also now have a projection for the drug's European approval date.

This revised information is now included in our news article mentioned in the posting we made directly above. The new information reads as follows:

Currently, The Beacon estimates that elotuzumab could be approved by the FDA and launched in the U.S. as a new treatment for multiple myeloma by late 2015 or early 2016. Approval in Europe is likely to follow shortly thereafter. Launches in specific European countries would then occur through­out the rest of 2016.

These projections are based on data provided to The Beacon by Evaluate Ltd., a market intelligence and analysis firm, and on discussions with financial analysts at International Strategy & Investment (ISI) and Sanford C Bernstein & Co.

For more Beacon news articles about elotuzumab, see the Beacon's elotuzumab "topic" (tag) page,

https://myelomabeacon.org/tag/elotuzumab/

Also, you can find a quick list of potential new myeloma therapies that are under development at the top of the Beacon's news page.