..."/>

Regorafenib Now Available Via Expanded Access

Click Here to Get updates from Fight Colorectal Cancer

The first four sites where colorectal cancer patients can get regorafenib are now open.  Bayer Healthcare expects to open additional sites in the next two or three weeks.

Colorectal cancer patients whose cancer has gotten worse on all standard treatments can now be considered for the Regorafenib Extended Access program.

Bayer Healthcare has applied for FDA approval of regorafenib to treat colorectal cancer, but until it is actually approved and on the market, the expanded access program is the only way patients who might benefit can receive it.

Last fall, early results from the randomized Phase 3 CORRECT clinical trial showed colorectal cancer patients who received regorafenib lived longer than a similar group who got a placebo.

Results of the CORRECT trial were discussed at the 2012 GI Cancers Symposium in January.  Axel Grothey, MD and his team concluded,

Statistically significant benefit in overall survival and progression-free survival was observed for regorafenib over placebo in patients with metastatic colorectal cancer who have failed all approved standard therapies. No new or unexpected safety signal was found.

Patients in the expanded access program will get regorafenib pills every day for three weeks, followed by a week’s rest before repeating the treatment cycle.

The first sites are now open in:

  • Sumter, SC
  • Charleston, SC
  • Jefferson City, MO
  • Aventura, FL

For additional information email clinical-trials-contact@bayerhealthcare.com

Related posts

19 Comments

  1. patti B said:

    would this be good for my husband he was diagnosed and had surgery for colon cancer stage 4 or 3c and can not afford chemotherapy drug Oxilplatin could he go on this expanded access program

    • Kate Murphy said:

      No, the Regorafenib Expanded Access program wouldn’t be right for your husband. It is designed for patients whose cancer has spread and who have no other approved options for further treatment.

      He would have had to have oxaliplatin already and had his cancer get worse. In fact, he would have had to have been treated with all the current standard treatments including 5-FU or Xeloda, irinotecan, oxaliplatin, Avastin, and if his tumor had normal KRAS,Erbitux or Vectibix.

      However, there may be a way to help get the oxaliplatin (brand name Eloxatin) supplied through the Sanofi Patient Connection.

      I can’t tell you if your family would be eligible, but you can call the Connection at 888-847-4877 Monday through Friday from 9 AM to 8 PM and explain the situation. Sanofi manufactures Eloxatin (oxaliplatin) and has help for patients without insurance.

      I also suggest you call the Fight Colorectal Cancer Answer Line and explain your husband’s situation. You can speak directly to an Answer Line Associate 9:00 AM – 5:00 PM Eastern time, Monday – Friday.

      There is help with the costs of other chemotherapy and prescription medicines.

  2. MK said:

    My brother’s physician has been trying to get this drug for him under “compassionate care” for over 6 weeks….Can you share what site in Jefferson City, MO is in the Expanded Access Program?
    Thanks Much,

    • Kate Murphy said:

      The Jefferson City, MO site is at Capitol Comprehensive Cancer Care Clinic. The doctor there who is the principal investigator for the expanded access program is Dr. Ali Khojasteh.

      We don’t have access information for all the current sites. The best approach is probably to email clinical-trials-contact@bayerhealthcare.com

  3. MK said:

    Thanks so much for your quick response! My family is very excited that there is expanded access in our area!

  4. Beth said:

    According to Mayo Clinic in Minnesota, this drug is not available until July due to distribution issues with Bayer. Can you comment on this?

    • Kate Murphy said:

      The expanded access program is not yet being implemented in all sites that are listed on clinicaltrials.gov and so may not be available at the Mayo Clinic yet.

  5. Heather said:

    I’m pretty certain my friend would qualify for this – I read the previous comments, and she has already received all the current treatments: 5-FU, Xeloda, irinotecan, oxaliplatin (eloxatin), Avastin, and Erbitux. I just wonder if she would have to travel to one of the states that have the expanded access, of if her hospital (MGH in Boston) can order it from one of those locations?

    • Kate Murphy said:

      I really don’t know the answer to that question.

      An expanded access program involves more than just getting the drug. In the regorafenib program, data about side effects is going to be collected similar to clinical trials.

      Whether she could travel once or twice to a program site and then have the drug given by her local oncologist is possible, I don’t know either.

      The best thing to do would be to talk to her local doctors and have them get in contact with doctors at a site that is part of the program to see what is possible.

  6. Donna said:

    I am having difficulty getting a response from the clinical-trials-contact@bayerhealthcare.com. Any other suggestions? I’ve also tried to contact our local Bayer Rep. Our doctors have patients who would be eligible for this drug. There is no phone number listed.

    Also, I was wondering if you could provide the names of the cancer centers, for those who have already been approved for the expanded access program just in case one of our patients is willing to travel if we cannot get it here in Virginia.
    Thank you

  7. Anna said:

    Hi MK,
    I was wondering if your brother’s doctor has been successful in getting your brother this new pill under compassionate care. If so could you tell how you go about it. This will be the only chance I will have for survival. I have that kraf gene mutation thing and with every attempt of any chemo I have suffered life threatening reations that often lasted 6+ months. I had been on vetibix for approximately 6 months. It was a weakened dose but i did great with it until about 4 months ago. My oncologist says it is no longer working and there is. nothing else he can do. His solution was to send me to a pain management clinic until I die. I am 58 – former FA – and can’t believe this is happening.
    I asked him to check into this regorafenib program. They want me to try the one other irinotecan and then they would let me into the expanded access program. The problem is that my former oncologist recommended that we not even try anymore of these chemos. I end up bedridden and react for 6+ months on each.
    The issue is that i most likely won’t have 6 months if i can’t find a drug like the regorafenib. Dear God I am beggining with my soul at this compassionate care acesses. I am so scared, so alone and about to give up. Why must I have to endanger my life again (possibly for the last months of my life – to prove i deserve this othe pill. I need any help i can get. Can anyone tell me what is the best way to approach this. I don’t want to leave this world yet. I want to see my grandchildren. I need a friend – please

  8. MK said:

    Anna,
    My brother is in the process of being evaluated for the drug. He had to have a surgery and under protocol they have to wait 4 weeks from date of surgery. Hopefully he will get it this Thursday. They have to do bloodwork and make sure kidney and liver function are good. They also want bloodpressure under control (can be medicated for that, is ok) They do a baseline catscan just to watch progress. Where do you live? Are you anywhere near an expanded access site? The first 8 weeks you have to go weekly (I think mainly to watch bloodpressure as it sounds like it will probably go up w/ this drug and may have to tweak meds to control)…after the first 8 weeks then it’s every 2 week visits. It’s a cycle of 3 week on and one week off. Prayers for you…..

  9. JWalker said:

    My husband has failed all forms of chemo treatment available and we are trying to get him into the expanded access program. Unfortunately, each site only has 15 slots available and we’re finding that there is already a waiting list. That means that just about as soon as the site it approved, it’s full. So from the way that things are looking, we will never get it in time.

    • Kate Murphy said:

      Hopefully the FDA will approve regorafenib quickly so that we won’t have to depend on the expanded access program.

      I understand how difficult this is for patients who have been waiting for a long time for this new medicine.

  10. JWalker said:

    According to what I’ve read, they have it slated for approval possibly in the late quarter of 2012, but it is more likely to be the 1st quarter of 2013. In order to qualify for it, you must have exhausted all other standard chemo before it can be used. Unfortunately that means that we are probably looking at 6 months out for this drug to be readily available. And realistically, a colorectal cancer patient whose cancer has progressed despite chemo, probably doesn’t have 6 months to wait.

    I just wish that they would make it available to oncologists thru compassionate care now. I understand about wanting to collect data, but with the number of sites in the US that are available, we’re looking at only 150 people who are able to get this drug right now.

  11. Heather Nixon said:

    “I just wish that they would make it available to oncologists thru compassionate care now. I understand about wanting to collect data, but with the number of sites in the US that are available, we’re looking at only 150 people who are able to get this drug right now.” I so agree :( Bummed to hear they are now projecting 2013 release. Indeed that will be too late for many, including, perhaps, my loved one. Been holding out hope for this for a while, still hoping it won’t be in vain.

  12. Rhonda R. said:

    I am an Oncology nurse navigator trying desperately to obtain Regorafenib for my pt who has failed ALL other chemo. We are referring him to Jefferson City for the expanded access drug. Can you tell me if that location has any drug available, or have they maxed out their limits (15)?? Help is much appreciated.!

  13. JWalker said:

    First off, thank you for trying to help this patient!

    Your best be would be to call the Jefferson site directly and ask them. I suspect that they probably filled up long ago though. The site local to us was full in April and it wasn’t one of the first to open :(

    Good Luck

  14. Charlene said:

    I am currently in clinical trial for Rengorafenib at Ochsner in New Orleans. I would like for Anna who posted in June 2012 to contact me by email at cookseyc@me.com

*

*


4 − one =

Top