[Multibilly]

Re: FDA approves Darzalex (daratumumab)

by Multibilly on Mon Nov 16, 2015 9:13 pm

MB,

Is this a test?

Interesting that maintenance is built into the dosing regimen (i.e. utilize the drug until disease progression - although it later states your healthcare provider will determine how many treatments you will receive). I guess the good news is that the IV infusion frequency goes to every other week at week 9 and then monthly at week 25. I haven't done the math, but I wonder how long an IV session is for a typical patient?

[Beacon Staff]

Re: FDA approves Darzalex (daratumumab)

by Beacon Staff on Mon Nov 16, 2015 9:19 pm

Sorry, Multibilly – we didn't mean for the question about the prescribing information (PI) to seem like a test. We were just wondering if anything caught people's attention as they read the PI.

The points you and Tracy highlighted are, indeed, interesting.

[Multibilly]

Re: FDA approves Darzalex (daratumumab)

by Multibilly on Mon Nov 16, 2015 10:15 pm

[DanielR]

Re: FDA approves Darzalex (daratumumab)

by DanielR on Mon Nov 16, 2015 10:58 pm

So does this expedited approval status mean that this drug is available now (assuming you meet the previous treatment criteria)?

[Beacon Staff]

Re: FDA approves Darzalex (daratumumab)

by Beacon Staff on Tue Nov 17, 2015 12:04 am

Daniel - The companies that have developed and will market Darzalex say that it "will be available for distribution in the U.S. within two weeks".

RadiantTiger - We're not aware of any published results that investigate whether patients respond differently to Darzalex depending on whether they have IgG, IgA, or other types of multiple myeloma.

[Maro]

Re: FDA approves Darzalex (daratumumab)

by Maro on Tue Nov 17, 2015 4:07 am

This is great news! Hopefully it will be approved for use in Europe soon.

However one thing puzzles me. If daratumumab has been approved and has also been proven to be very effective (even as a single agent) and with little to no side effects, then why do we only decide to use it after a patient has gone through hell with 3 previous treatments?

Why not use it upfront and possibly keep the patient on a long remission with good quality of life until progression? This leaves time for new drugs to come out and maybe the patient will respond to daratumumab for a very long time.

Am I mistaken in my reasoning?

[JPC]

Re: FDA approves Darzalex (daratumumab)

by JPC on Tue Nov 17, 2015 7:50 am

Hello, Maro:

You ask a very good question. The short answer is that the studies for daratumumab with relapsed / refractory patients finished earlier. They were the backup data for the application. As for the studies with daratumumab being applied in different settings, they are ongoing. When they advance, the application will be updated, and additional approvals will be granted based on the updated data (assuming the data is good). That is the way the system works. In theory, its for the safety of the public, that an unsafe drug does not get pushed out and approved too fast.

Regards, JPC

[JPC]

Re: FDA approves Darzalex (daratumumab)

by JPC on Tue Nov 17, 2015 8:01 am

Hello RT:

You ask a very good question, and the answer from the Beacon staff I think is correct, no data in clinical studies. However, I will add that the monoclonal antibodies are a new class of drugs that act on the surface of bad myeloma cells. They recognize proteins on the surface of myeloma cells that are not on the surfaces of regular blood cells.

In the case of daratumumab, the target is CD38 (whatever that is). So I have read and heard doctors state that although we do not know for sure, it seems that so far it does not matter the type of what's inside, the monoclonal antibodies so far seem to work equally well for the differing types; and that is very good for the high risk cytogenetics, del(17p), t(4,14), t(11,14), and t(14,16), which are internal to the cells. That is why certain of the leading researchers are excited about the approvals coming in for the monoclonal antibodies.

By the way, have they cleared up your fever? Are you doing better? I hope so.

[Nancy Shamanna]

Re: FDA approves Darzalex (daratumumab)

by Nancy Shamanna on Tue Nov 17, 2015 9:39 am

In this article from Wikipedia, 'clusters of differentiation' are described (CD is an acronym for 'cluster of differentiation'). They are surface molecules which may be used as antigens, and they were numbered in the order of discovery. There are more that 360 CD's, so CD38 was discovered early in this system. The CD38 is found on the surface of myeloma cancer cells, and that is why daratumumab can attack those cells and leave the healthy cells alone.

It is really encouraging to realize that another type of pharmaceutical has been approved in the US to treat myeloma, apart from IMID's and PI's (immunomodulatory agents and proteasome inhibitors).

[brandyjoco]

Re: FDA approves Darzalex (daratumumab)

by brandyjoco on Tue Nov 17, 2015 1:21 pm

Ok - this is over my head - but I am thinking that this research study from 2011 is showing that Daratumamab can effectively kill multiple myeloma cells without hurting healthy cells, for all multiple myeloma patients irregardless of whether the patient has received prior lines of therapy. This is quite exciting.

http://www.jimmunol.org/content/186/3/1840.full