Access to new drugs outside of the US is frequently delayed by several years following FDA approval in the US. For example, lenalidomide (Revlimid®) received US FDA approval in June 2006, yet is still not fully approved and available globally. This lack of access has a significant negative impact for myeloma patients. At the point of relapse, patients who may have been treated frontline with VTD (Velcade®, Thalomid®, dexamethasone) or CyBorD, only relatively recently and in some cases have been able to turn to Revlimid®.

In the case of pomalidomide (Pomalyst®), the most recently approved IMiD (approved in the US for relapse/refractory disease in February 2013 and in Europe in August 2013), global access is currently very limited. Pomalidomide is not available for relapsing patients in Asia.

The IMF’s Asian Myeloma Network has therefore negotiated with the Celgene Corporation to establish an individual or “named” patient access program for pomalidomide. Utilizing a treatment protocol very similar to the trials conducted in the US and Europe, eligible relapsing patients can now gain access to pomalidomide through the main Asian treatment centers. After overcoming numerous regulatory and logistic hurdles, the protocol was activated in December 2014 with Dr. Wee Joo Chng as the principal investigator. Dr. Chng, an IMWG and AMN member, is based at the University of Singapore where the data management and coordination center is housed and funded.

Accruals started rapidly in Korea with Dr. Jae Hoon Lee, who enrolled four myeloma patients in December. He is excited to report that at first follow-up, all patients showed evidence of response and excellent tolerance. Patients are now enrolling in Singapore, to be followed by Thailand, Hong Kong, and Taiwan. Unfortunately, it is not yet feasible to open the program in Japan and China, the other two AMN members.

The successful launch of this pomalidomide access program is very exciting for both patients and physicians in Asia. This is a model through which patients can gain early access to new drugs which can be literally lifesaving! It is hoped that it is just the beginning of programs to enhance global access to new FDA approved drugs, which are so desperately needed to improve myeloma patient survival.     

Dr. Durie sincerely appreciates and reads all comments left here. However, he cannot answer specific medical questions and encourages readers to contact the trained IMF InfoLine staff instead. Specific medical questions posted here will be forwarded to the IMF InfoLine. Questions sent to the InfoLine are answered with input from Dr. Durie and/or other scientific advisors and IMWG members as appropriate, but will not be posted here. To contact the IMF InfoLine, call 800-452-CURE, toll-free in the US and Canada, or send an email to infoline@myeloma.org. InfoLine hours are 9 am to 4 pm PT. Thank you.

Comments

Please integrate African relapsing patient to this life saving drug. Virtually none of the novel drugs is available and very poor patient are being hopelessly exploited . Being a Doctor and a patient myself i am willing to assist make this program/integration work well.

Hello,

My name is Pooja Bansal. The purpose of my email today is to seek financial aid for a drug called Darzalex which is manufactured by Janssen (J&J).

The drug is approved in the United States but is not available in India. I was told that IDIS is the right channel to write to, to obtain information. However, when I contacted IDIS, I was told that no subsidized pricing (unlike patients in United States) is available for patients in India.

My Godfather is suffering from Multiple Myeloma since 2010. He went through a major surgery in India towards the end of 2010 which was unsuccessful. From the reports of the surgery it was found out that he also has colon cancer. He underwent another major surgery. This time it was for colon cancer. The surgery was successful and so far he is blessed to not have it back. In 2014, he went through another surgery for multiple myeloma. No success. Since then he has been on Velcade. My father is 71 years old.

For the last 2 months he is bed ridden due to immense pain. The oncologist (Dr. Shyam Aggarwal at Ganga Ram Hospital) has told us that he cannot undergo any surgeries because his body will not be able to take it. His platelet cells have dropped to 40,000. According to the oncologist, his current medication for multiple myeloma is not working and the only medication available that could work is Derzalex.

I am writing to you to seek financial aid for this medication. There is no means for me to be able to afford this medication so I am writing to you for help.

My father is in immense pain and I do not know what I can or should do to help him. I had to start somewhere and so my email to you. Please help...

Any help/information will be appreciated. I hope to hear back from you soon.​

Thank you,
Pooja Bansal
pooja.bansal@gmail.com

[personal questions will be answered offline by the IMF InfoLine team.]

Add new comment