Monday, December 12, 2011

ASH Conference Post # 5 - How Novel Is Novel?

New Novel Drugs:

As everyone knows (?), the "novel" drugs used in treatment of myeloma are thalidomide, lenalidomide (Revlimid), and bortezomib (Velcade). This trio has revolutionized the treatment of myeloma in the recent few years, probably almost doubling the survival time of newly-diagnosed myelomiacs.

But there are more new drugs coming, lots of them, with carfilzomib and pomalidomide leading the pack. From an outsider's view, those two are about equally potent and equally close to FDA approval. Both are hugely successful in treating myeloma, often even in patients for whom the novel drugs have failed. Both have successful Phase II trials to recommend them, but neither has a Phase III trial.

Onyx has submitted carfilzomib for FDA review and requested priority review. The FDA has accepted it for review, but declined priority review, so it could take until summer. So far. Celgene has not yet submitted pomalidomide for review, but according to one source, may submit it by the end of the month.

These two could be FDA approved within a year. Then which are the novel drugs? Do we have a cast of five, or two neo-novel drugs and three post-novel drugs? I'm sure someone smarter than me will figure out how to classify them.

Pomalidomide Study:

Long-term Outcomes of Pomalidomide and Dexamethasone in Patients with Relapsed Multiple Myeloma: Analysis 4 Years After the Original Cohort

This is the study that I am in. I started taking pomalidomide three years and nine months ago. Most of the patients enrolled in the study were sicker than me, in Stage 2 or 3, where I was in Stage 1. Many had lots of prior failed therapies. Nevertheless, half of the standard-risk patients (like me) remained progression-free for at least 18 months, with a 2-year survival of 85%. Twelve of the original 60 patients are still on the drug - I am one of those, about to complete Cycle 49. I can stay on it as long as it works. Here's hoping.

Cornucopia of New Therapies:

Dr. Robert Orlowski, a well-known myeloma expert, used that phrase Friday night. I love it and will definitely quote him at my next support group meeting.

I get an overwhelming sense of hope at this conference. Things are really happening. Just today I counted 80 posters on myeloma alone. In the three days of poster talks, I suppose there will be 200 to 250, just on myeloma, each representing serious scientific research. Not all, maybe even not most, will be investigations of new treatments, but many are. All of the papers advance the science significantly.

Treatment options are expanding almost daily. There is SO much hope this year - stay alive for it.


  1. Don - Thanks for all the updates from ASH, sounds like a very interesting conference. I was diagnosed with Myeloma in Feb 2011, had induction and ASCT over the summer. A year ago did not even know what Myeloma was or that such a conference existed.

  2. Don, thanks for keeping an eye on things. I really value your blog -- and your inspiring example.