[Beacon Staff]

FDA approves Revlimid for newly diagnosed myeloma

by Beacon Staff on Wed Feb 18, 2015 11:33 am

Celgene announced this morning that the U.S. Food and Drug Administration has approved Revlimid for use, together with dexamethasone, in the treatment of newly diagnosed multiple myeloma patients.

This is an expansion of Revlimid's approved use in the U.S. Previously, Revlimid had only been approved by the FDA for use in relapsed myeloma patients.

The practical implications of this development are likely to be limited, as so-called "off-label" prescribing of Revlimid -- that is, prescribing that is beyond what is in the officially approved prescribing information -- is common in the U.S., including prescribing for newly diagnosed patients.

Here is a link to Celgene's announcement of the FDA decision, which was issued about an hour ago:

"FDA Expands Indication For Revlimid® (Lena­lido­mide) In Combination With Dexa­metha­sone To Include Patients Newly Diagnosed With Multiple Myeloma," Celgene Press Release, Feb 18, 2015.

As you'll see, the approval is based on data from the "FIRST" clinical trial, which compared treatment of newly diagnosed myeloma with continuous Revlimid-dexamethasone therapy and two other alternative treatment regimens. The trial results are discussed in this Beacon news article and in this New England Journal of Medicine article.

Celgene also has applied for a similar expanded approval for Revlimid in Europe and is expected to receive a positive decision on the application in the near future. This will have a more significant impact than the FDA's decision, as off-label prescribing of myeloma therapies is uncommon in Europe.

What are your thoughts on the FDA expansion of Revlimid's approved use? Would it have affected how you were treated as a newly diagnosed multiple myeloma patient?

[Rneb]

Re: FDA approves Revlimid for newly diagnosed myeloma

by Rneb on Wed Feb 18, 2015 7:37 pm

Thoughts ? Less toxicity.

If No Velcade--No PN Grade II-III.

Velcade brought down my M Spike after Induction--but damn, that stuff is hard on you--even with the Steroids to help out with healing.

The Peripheral Neuropathy in the toes, feet, ankles, and lower legs, has probably been the most irritating aspect of the entire treatment(s), for me. Nothing touches it....tried everything. 3 years now.

The bowel PN is a close second. It's either painful Constipation or angry Diarrhea.....

Both major Quality of life issues.

Revlimid is not nearly as severe--just magnifies the damage the Velcade did.
Stiffness, soreness, joint pains, and related musco-skeletal issues are tolerable.

When off Revlimid, even for two weeks, it seems that it's effects dissipate....and fairly rapidly.

[gardengirl]

Re: FDA approves Revlimid for newly diagnosed myeloma

by gardengirl on Wed Feb 18, 2015 7:59 pm

Isn't there a link of Revlimid to secondary cancers? (That's what my doctor mentioned.)

[Beacon Staff]

Re: FDA approves Revlimid for newly diagnosed myeloma

by Beacon Staff on Wed Feb 18, 2015 8:51 pm

We've published our news article following up on the press release we mentioned in our first posting in this thread. Here is a link to the article:

"FDA Broadens Revlimid's Approved Use To Include Newly Diagnosed Multiple Myeloma," The Myeloma Beacon, Feb 18, 2015.

There were a number of changes to the official, FDA-approved prescribing information beyond just the change in Revlimid's approved use, and we describe the key changes in our new article. Some of that information addresses questions or points made in this thread thus far.

Thanks!

[Mona]

Re: FDA approves Revlimid for newly diagnosed myeloma

by Mona on Thu Feb 19, 2015 6:01 am

Does this new approval imply a common treatment will be Revlimid and dex alone and not with a 3-drug combination such as with Velcade (RVD) or Kyprolis (RKD)?

I recently relapsed with a small plasmacytoma in a soft tissue around my lung. My doctor considered having me on just Revlimid and dex, but I wanted all 3, so I've just started Kyprolis , Revlimid, and dex. I will take that for 2 cycles, then reassess the tumor and perhaps go to just Revlimid and dex at that time.

I had a high-risk myeloma stage 3 when diagnosed in December 2012 , had RVD, then a stem cell transplant and was in complete response from December 2013 for about a year.

Any comments or suggestions on my treatment plan?

Thank you