Just got this via email
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September 16, 2005 at 12:32 am #8744TerriMember
FDA Oncologic Drugs Advisory Committee Recommends REVLIMID for Full Approval
Celgene Corporation announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) recommended full approval of REVLIMID(R) (lenalidomide) for the treatment of transfusion-dependent patients with myelodysplastic syndromes (MDS) with 5q minus with or without additional chromosomal abnormalities. The committee based its recommendation on clinical data from an open label Phase II trial evaluating REVLIMID(R) in MDS patients with deletion 5q chromosomal abnormality.
The FDA expects to complete their review and decision by October 7, 2005.
According to Marilyn Baker, AA&MDSIF Executive Director, “Today’s recommendation by the Oncologic Drugs Advisory Committee (ODAC) to approve Revlimid gives patients with myelodysplastic syndromes (MDS) a welcome new treatment option for this potentially fatal blood disorder. This is particularly exciting news as MDS is a rare and often overlooked disease that does not receive the kind of research and development funding that other conditions do.”
Read Celgene’s press release at http://www.celgene.com and FDA’s Briefing Document for the September 14, 2005 Oncologic Drugs Advisory Committee Meeting
September 17, 2005 at 2:06 am #8745Sandy LMemberHi Terri,
Mike’s doctor said they called Celegene and they said it would not be approved by Oct 6. He has to start Vidaza yesterday and the first treatment did not go as well as we hoped. The nausea and vomiting that night was terrible. Today he had another shot and they gave him a anti-nausea drug intervenously and so far so good. His numbers are very low and he will need platelets on Sunday with the Vidaza shot at the hospital. I too agree that you are very lucky with a very good doctor. I do think we have found someone who is competant and caring and we will be sticking with this one. My suggestion to anyone who is not happy is keep trying………..
Sometimes when you call and speak to receptionist they do not even know the term MDS. Ask to speak to the Office Manager and then go into detail and ask all your questions. The girls at the front desk are not the ones that you want to speak to.My son is coming in tomorrow. We are looking forward to the visit. If you have a chance I would love to speak to you. Hope Bob’s last test came back with goo numbers.
September 17, 2005 at 3:23 pm #8746dinerMemberSandi,
I’m so sorry Mike had such a time with his first treatment of Vidaza. I have secondary MDS and started Vidaza Sept. 6. I’ve had 9 shots and have done well. I am taking a lower dose which was recommended but with good results (10 days instead of 7). I take Kytril pill before my shot and I’ve never been nauseous. My main problem is from the shot site and constipation. I get my last shot for the month on Monday and prob. a tx on Tuesday. My platelets were only 3,000. Yes, it’s great to have a doctor you trust.September 18, 2005 at 8:05 pm #8747TerriMemberSandy, The first day Bob did Vidaza he went through the same as he touch the antinausea pill after the shot and then could not hold anything down. Now he does the Zofran ODT before we leave it is the type that melts on your tongue. No problem after that I hope Mike starts doing better on the Vidaza.
Diner, Bob gets bruising and red at the sites of the shots. He hates them in the stomach and will not take them there any longer , we started using the arnica gel for the brusing it helps somewhat as does the Bromelain supplements.September 19, 2005 at 7:34 am #8748Sandy LMemberHi Diner and Terri,
Thank you so much for your good wishes. Mike had his shot Fri, San and Sunday and with plently or nausea medicine he is now okay. The plates went down to 15 so he had platelets today in the hospital. We were there from 12 to 7 PM. The blood comes from WPB and they had to type him again. Does he have to get typed everytime? Can’t he carry a card? Anyway they now want him to have another tx tomorrow, but the doctor wants to see him in the office before then. He RBC is down to 7.6 – All his numbers are way down. He is tolerating the shots very well. He had both arms and both sides of the stomach. The site are is red and bruised but he has no discomfort. The bad thing is he has a terrible infection in his mouth. Right side upper gum area. He is taking pain killers every two hours and says the [ain is unbearable. After the docotr, and hospital we will try to go to the dentist.
Where do you buy arnica gel? and Bromelain supplements.?
Diner good luck on your last shot. And Terri how is Bob’s counts? Are they going up?
September 19, 2005 at 11:01 am #8749eveMembermy dad has to get has to get blood typed everytime he has a tx – and it can only be done within 72 hours of the tx – it is not just to see what type blood he has (your blood type doesn’t change) but to check for antibodies in the blood that can change everytime you have a tx
eve
September 19, 2005 at 11:50 am #8750sarahMemberSandy , keeping you and Mike in our thoughts and prayers. My husband is going to hospital today for cross typing prior to tx. He is having spleen removed this Wed. morning. I am very concerned his counts are quite low.
September 20, 2005 at 3:02 am #8751Sandy LMemberSarah
I will be looking for your posts. Good luck on Wed. and be sure that I will be praying for you.
Good LuckSeptember 20, 2005 at 3:04 am #8752Sandy LMemberEve
Thank you for clarifing that for me. I did not know why they had to cross match every third day.
September 20, 2005 at 12:16 pm #8753NeilMemberHi Sandy,
Mike might want to try Rincinol for his mouth infection. Available over the counter. It helped me with a mouth infection. Reduced pain and may have helped healing.
NeilSeptember 20, 2005 at 1:08 pm #8754TerriMemberSandy, Bob uses the Rincinol as well it works wonders.
September 21, 2005 at 3:37 am #8755dinerMemberHi everyone, I had my last shot of Vidaza for the month yesterday. I could hardly walk on one leg for 3 days from 1 shot that gave me a lot of pain. My WBC was 2. and my HGB was 7.l and my platelets were 7,000. I got 2 units of red cells today, but my doctor called tonight and is concerned about my platelets and bleeding internally somewhere. I have to go in for another blood test tomorrow. He’s thinking of putting me in the hospital for platelets tx’s. I’m his first pt on Vidaza and he’s nervous. He’s working closely with Dr. Peter Curtin head of MDS Center at OHSU. I don’t know how many platelets I would have to have. Is Bob or Mike on any kind of medicines that’s suppose to keep them from getting mouth sores?
September 21, 2005 at 6:11 am #8756Sandy LMemberHi Diner
Sorry to hear that you are not doing so well. I do hope that tomorrow is a better day – hang in there. Were you given the shot in the thigh? Is that the reaason for the pain in the leg?
Mike will be finishing his last shot for this month tomorrow. He too is getting tx and platelets. They might have to do platelets again tomorrow. His doctor is also concerned that he might be bleeding , but he took a stool culture and so far no internal bleeding. After the first day with the bad reaction (nausea and vomiting) they gave him a lot of anti-nausea drugs and they are working. This morning we headed to the dentist and he needed a root canal. He tolerated it well and stopped bleeding quickly even though his platelets are 15.
Thank you everyone about the tip on Rincinol. I will buy it tomorrow. He is still in such pain from the tooth even after the drainage. The dentist said that he has seen many people that after chemo have very decayed gums. The dryness in the mouth is the reason he gave. Mike has been exceptionally thirtsy and drinks continuously for at least a month now. He only started the Vidaza 6 days ago and that infection appeared at least 5 days ago. Can it cause so much havoc in only one day? We will go back tomorrow to see what they say. He is popping Percocet every two hours.
The injestion sites from the Vidaza are red but he is not sore or tender. He did say that he is getting a lttle light headed and is having trouble concentrating. ( Like adding up a row of numbers) He also said that while sitting on the couch his eyes would close (while he is sitting up) and then he thinks he cat-napped and awakes startled. Has anyone experienced anything like this? -
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