Concerned about FDA secondary cancer warnings when using Revlimid?

I’ll bet that no one else noticed this feature on Sokolove Law, LLC’s website?

Monday I shared the disappointing news about how the promising anti-myeloma drug, perifosine, might not ever make it to market.

Although this Cancer Network article never mentions multiple myeloma specifically, it could be all about myeloma.

Last night I attended a media reception, hosted by Onyx Pharmaceuticals at the Omni Hotel in San Diego.

This is a perfect example of how sadness and despair can turn to hope in the blink of an eye…

The International Myeloma Foundation (IMF) reports that pomalidomide and carfilzomib “are both moving closer to approval for patients who have relapsed or do not respond to current drugs.” in their summer addition of Myeloma Today.

The Myeloma Beacon just broke the story about how the FDA is investigating Revlimid and Thalomid, based on research data showing a possible secondary cancer risk following long term, post transplant use.

Here is an independent look at the pending investigation by Internal Medical News.  I have highlighted key points I feel are important:

Last month I broke a story about the new, experimental anti-myeloma novel therapy agent, carfilzomib:
This Just In: FDA Announces Fast Track Designation For Carfilzomib.

I wanted to share this wonderful news right away…
Here is an e-mail I received from a contact who works closely with Onyx Pharmaceuticals, Nadia Hasan:

I recently saw a news story about how Bill Gates and Warren Buffet are crisscrossing the globe, meeting with fellow billionaires in an attempt to get them to commit part of their fortunes to help solve the world’s problems.

Hot “off the presses,” here is yesterday afternoon’s announcement from the FDA as reported by Reuters:
FDA OKs Amgen’s bone drug in certain cancers
Nov 18 2010 – By Deena Beasley

* Denosumab approved for patients with solid tumors
* Not approved for multiple myeloma
* Shares rise 1.6 percent

Yesterday I reported that Onyx Pharmaceuticals had temporarily delayed their drug application with the FDA for the new and highly anticipated anti-myeloma drug, carfilzomib.

I received this disappointing, although not unexpected e-mail from Lori Murray, Director, Corporate Communications & Investor Relations for Onyx Pharmaceuticals late yesterday:

Yesterday I had a little fun with the “what if” game. What if there was a generic form of Revlimid? How would that affect patients and future drug development if all of those long term profits were lost?

I just concluded attending an online press conference with officials from Onyx Pharmaceuticals, manufacturers of the experimental anti-myeloma drug, carfilzomib.

The International Myeloma Foundation alerted me that the American Society of Clinical Oncology (ASCO) was unveiling a new resource this month to help seriously ill patients and their physicians request expanded access to investigational therapies when they have exhausted all other treatment options and the patients are not eligible for a clinical trial. The website was announced by the American Society of Clinical Oncology and the Food and Drug Administration. Patients and physicians can access the new resources, free of charge, through ASCO’s physician education Web site, Expanded Access To Investigational Drugs.

My good friend at Millennium, Manisha Pai, forwarded me this press release about the new VISTA/Velcade study results last evening:

Here is a link I found helpful from the International Myeloma Foundation (IMF), referencing six different research studies that are still accepting multiple myeloma patients:  Carfilzomib Treatment Studies.  As you may recall, there was a lot of excitement about carfilzomib’s potential to reduce some of the side effects associated with a similar drug, Velcade, at last Decembers ASH conference in New Orleans. Keep in mind, Velcade is already FDA approved for use in newly diagnosed as well as multiple myeloma patients who have relapsed.  But early studies have shown Carfilzomib to be effective for some refractory (relapsed and drug resistant) myeloma patients. 

My wife Pattie and I just wrote an article about accelerated FDA approvals for drugs which might help patients with rare cancers titled “Orphan Drug Status For Experimental Cancer Drugs Getting Boost From FDA.”  There is an additional link there to a Wall Street Journal story on the subject–which directly affects multiple myeloma patients.