Tuesday, April 15, 2014

Please sign this petition!

Joey Xu is a fourth grade student from Gainesville, Florida.  He is an artist, plays violin, and loves science, math and reading.  He is also a Boy Scout and an avid origamiist.  My son also insists that I tell you that Joey is really fun and kind.

In March, 2013, two weeks after his 9th birthday, Joey Xu was found to have an abdominal mass on his left kidney. His diagnosis was a form of  kidney cancer that is so rare that there are no pediatric specialists for this type of cancer in the country, and no standard treatment protocols.  Even after a year of treatment, including 2 major surgeries, several courses of chemo and other drugs, his tumors have grown and spread.  He now has tumors throughout his chest, abdomen, pelvis and neck.  They are affecting his ability to eat, and will soon affect his ability to breathe. 

However, a new line of immunotherapy drugs that target the type of tumors that Joey has (tumors expressing PD-LI) are being developed, including one called Nivolumab by Bristol-Myers Squib, MPDL3280A from Genentech and MK-3475 from Merck.  Nivolumab is already in trials and saving the lives of adult cancer patients.  Pediatric trials of Nivolumab were due to start in March, but were delayed until October, and the aggressive nature of Joey's tumors mean that he can not wait that long for access to the drug. Genentech has an adequate supply of MPDL3280A, but both companies need to be pushed to let Joey use them.

Joey's doctors  at Shands/UF and the Cincinnati Children's Hospital  and an immunotherapy specialist at Harvard have determined that his tumors are likely to respond to Nivolumab or MPDL3280A and his oncologists are willing to oversee compassionate use of these drugs.  His family fully understands the risks with experimental medicine, but they have nothing to lose, and much to gain.  

Please sign the petition, forward to your friends, and help publicize Joey's story. Hopefully Bristol-Myers Squibb or Genentech will grant compassionate use of one of these new drugs to Joey, so that he can continue to grow, and play, and learn, and do all the other things a 10-year old should do.  

Please share widely right now! If you have any connections with media outlets that can help us get this link out to more people, or to the decision makers at Genentech or Bristol-Myers Squibb please leave a message at Joey's Facebook page https://www.facebook.com/xp11.2TFERCC or email Joey's mom, Kathy, at kathyoasis@yahoo.com

Monday, April 14, 2014

Compassionate use of drug

Joey needs your help. This is how bad Joey's tumors look. The solid black parts are brain, heart, bladder, etc and all other areas in tummy, plevis, chest, airway, neck are his tumors. All these tumors are eating out his energy, nutrition and his tiny body.
Now there is one drug, a promising new drug, can possibly save his life. It's called Nivolumab from Bristol-Myers Squibb Corporate. It's one of the anti-PD-1 or anti-PD-L1 immunotherapies. This drug has saved the lives of many late stage adults RCC patients. The pediatric trial of this drug was supposed to start in May, but now postponed to Oct. We cannot wait for the PD1 trials to start in children as they keep on being postponed and Joey needs treatment urgently. A lab in UF tested both Joey's primary tumor and lymph node tumors, they all tested positive to PDL1. His oncologists in Cincinnati Children's and Shands and an immunotherapy specialist in Harvard believe the anti-PD-1 or anti-PD-L1 immunotherapies, including Nivolumab, are the most promising option for Joey and they will request the compassionate use of the drug from FDA.

For the grant of it, there are two important things: The drug company must agree to allow the use of their drug outside of a clinical trial. The FDA oncology medical officer in charge of overseeing the new drug’s development must approve the use of the drug. My dear friend, who is a lobbyist, will contact Florida congressmen and senators and the general attorney of Florida and they will send my letter to the drug company. So please, if you happen to have some connection with government or this particular drug company, please contact me. Please spread the words. This is a very hard and long process, but we will try our best. I probably will run the social campaign, newspaper, TV station and online petition, anything we need to do. If you have experience or any suggestions, please let me know.

This is all very overwhelming to me and I hear the clock clicking. Joey is not doing well. He is very tired all the time. When he eats, he puts his hands on the stomach to make him comfortable. I can literally feel his tumors in tummy and neck. They are bigger. They are aggressive. Dr. worries about tumors by his airway and asks me to watch his breathing. I want to pull him out of school and rest. But he doesn't want to miss FCAT again this year. So I took him home after the test. Looking at his report card, I can't help crying. All "A", he never bring a "B" home despite of so many absent and tardiness. I can't watch him eaten away by tumors knowing there is a promising drug out there, but we can't get it because of the system.

Please help us, any suggestion is appreciated! Again the drug is Nivolumab from Bristol-Myers Squibb Corporate. I need contacts in the government and this drug company. Thank you all for your supports!