Avastin

On March 31, 2009 -- this Tuesday -- the FDA will hold an open public hearing to discuss approval of Avastin as a single agent in previously treated glioblastoma multiforme. The hearing will take place from 8:30 a.m. to 4:30 p.m. at the Hilton Washington DC/Silver Spring. Although this hearing is for an adult indication, we believe this matter deserves the attention of the brain tumor community at large. Moreover, we are seeing Aavastin being used with our DIPG kids more and more frequently.

There is some concern in the adult community that a negative review from the FDA will result in insurance companies refusing to pay for Avastin for any brain tumor patient.

Because this is an issue that may very well directly impact the DIPG community specifically, and most certainly will impact the entire brain tumor community, we delivered the following letter in support of Avastin for the Committee's consideration:


ODAC Committee Members:

We, the Board members of Just One More Day, are writing to urge the Committee to recommend approval of Avastin as a single agent in recurrent glioblastoma multiforme.
Just One More Day is a non-profit foundation formed by parents to help other parents whose children have been diagnosed with pediatric diffuse intrinsic pontine gliomas (“DIPG”), a cancerous tumor which invades the brainstem. DIPGs are almost always terminal, with most children dying within one year of diagnosis. In thirty years, and despite multiple different trials, no chemotherapy has been found to be effective against DIPG. With Avastin, however, there is hope.

Although DIPGs are generally considered inoperable, DIPG lesions were biopsied as part of a recent French study. The study revealed that the vast majority of DIPGs are high-grade gliomas, with many being glioblastoma multiforme.

In our network of parents we have seen many of our children with DIPGs stabilize with Avastin. In fact, we have recently been overjoyed by dramatic regression of the DIPG in Andrew, son of one of our Board members, after he received a single cycle of Avastin. Avastin has provided a flicker of hope in the dismal world of diffuse intrinsic pontine gliomas.

We realize that the question before the committee is whether to recommend approval of Avastin as a single agent in recurrent glioblastoma. Unfortunately, the call for written testimony did not indicate whether the question addresses both adults and children or only adults. Regardless, we believe it is important that our voice be heard on the matter. We are directly impacted by what is being done for adults with brain tumors, as treatments are usually not approved for children until they pass through the approval process for adults. Articles such as Antiangiogenic Therapy Using Bevacizumab in Recurrent High-Grade Glioma: Impact on Local Control and Patient Survival (J. Neurosurg. 2009 Jan; l 10(1): 173-80)) are encouraging and reflect what we are seeing with our children.

We ask the committee pause and reflect on the impact of this recommendation to the entire brain tumor community -- including our children. Previously there has been so little hope for children with DIPGs. Even a little more time with our children – even, as our name reflects, just one more day -- is incredibly precious to us. Please help the flame of this hope continue to burn and, we hope, to grow even brighter.

None of our board members have financial conflicts regarding the approval of Avastin.

Thank you for your time and consideration.



Background information is available at-
Meeting background http://www.fda.gov/ohrms/dockets/ac/cder09.html#OncologicDrugs
27 page document from Genetech http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4427b1-01-FDA.pdf

DIPG Digest

DIPG News brought to you by:
Just One More Day for Love, Hope & a Cure
http://www.justonemoreday.org/


Medical News
p16 promoter methylation in the serum as a basis for the molecular diagnosis of gliomas.: http://www.ncbi.nlm.nih.gov/pubmed/19240607?ordinalpos=5&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

Interferon-beta, MCNU, and conventional radiotherapy for pediatric patients with brainstem glioma.: http://www.ncbi.nlm.nih.gov/pubmed/19260101?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

Targeting multiple kinases in glioblastoma multiforme.: http://www.ncbi.nlm.nih.gov/pubmed/19243279?ordinalpos=29&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

National Childhood Brain Tumor Prevention Network Act of 2009

Advocacy Resource Center-
http://www.justonemoreday.org/Advocacy/Advocacy.html
http://tinyurl.com/b7zsku

Yahoo Group-
CBTPN · Childhood Brain Tumor Prevention Network: http://groups.yahoo.com/group/CBTPN/

State Resolutions to Support S. 305 and H.R. 653: http://www.justonemoreday.org/Advocacy/StateResolutions.html


FDA Open Public Hearing on Avastin

March 31, 2009
from 8:30 a.m. to 4:30 p.m. Hilton Washington DC/Silver SpringThe Ballrooms8727 Colesville Rd., Silver Spring, MD301-589-5200.

Information from the FDA: http://www.fda.gov/OHRMS/DOCKETS/98fr/oc20098-nm.pdf
Background information available March 29, 2009: http://www.fda.gov/ohrms/dockets/ac/09acdocs.html


Foundations News

Moss Report Newsletter provided by MJ's Children's Glioma Cancer Foundation: http://www.marcjr.org/FoundationMembers/MossReport/tabid/461/Default.aspx

The Cure Starts Now http://www.thecurestartsnow.org/

The Cure Starts Now is happy to welcome Jon and Anne Cinnelli and Marc and Emily Quayle to our strategic council. Both families know all to well the struggles we face in the fight against brain cancer and have made a major financial contribution to The Cure Starts Now and we look forward to their leadership contributions now. Their place on the strategic council will help guide us to the first 10-13 branches of CSN opening by years end. They will also help the existing strategic council decide on funding more research grants (our second funding cycle in 6 months). We are excited about the new partnerships and being able to broaden our operations. If you would like more information in joining these families in their combine fight against brain cancer, please contact me at brooke@thecurestartsnow.org.
Please join us on April 4th in Macon Georgia for the Imagine a Cure Music and Food Festival benefitting The Cure Starts Now. Organized by Patsy Mercer whose relative, Brayden Harrell, lost his battle with brain cancer. The event will be a wonderful tribute to him and other children who have and will battle brain cancer. Visit http://2009imagineacure.com/ for more details and we hope to see you there.


For past issues of DIPG Digest please visit http://www.justonemoreday.org/ParentPointers/DIPGDigest.html

Please submit information you feel will be helpful to DIPG families to JustOneMoreDay@cfl.rr.com subject: DIPG Digest

Copyright 2008 - 2009 Just One More Day for Love, Hope & a Cure, Inc. All rights reserved. The materials and links provided on this site have been prepared for information purposes only and should not be construed as advice or opinions on any specific facts or circumstances. Medical research concerning disease and treatments is an ongoing process. Readers should not act upon this information, but should obtain advice from physicians, medical institutions or other professionals, as appropriate.

A simple way to change the future

I personally know of 135 children who have passed away because of a DIPG since my daughter Alicia was diagnosed with this terrible cancer in 2005. After their children were diagnosed, these 135 families had about 12 months to accomplish a lifetime of dreams with their children. They will never see their child go on their first date, drive a car, graduate from high school, get married or have their own child.

Diffuse intrinsic pontine glioma is one of the worst brain cancers, with no real effective treatment and no cure. Some doctors believe finding a cure for DIPGs may very well lead to a cure for all brain tumors. We desperately need to fund research. We need to change the future for our children and grandchildren.

Thank you for supporting Just One More Day and helping us raise awareness for DIPGs. Now I'm asking you to take it a step further; I'm asking you to visit http://www.firstgiving.com/21687 and develop your personal page to benefit Just One More Day for Love, Hope and a Cure.

If 100 of our wonderful supporters donate just $5.00, we would raise $500.00. But, if each of us sets up FirstGiving page and 50 of our friends donate $5.00, the amount we raise increases to $25,000.00. With this money we could begin funding a research protocol - the first step to finding a cure.

Starting a page at FirstGiving.com is quick and simple. After your page is ready, you can e-mail it to friends, family and colleagues. You will continue to raise awareness about this rare disease and will also allow those who wish to help to donate by credit or debit card in an easy, secure, online transaction. Please take a moment and look at my daughter's FirstGiving page at http://www.firstgiving.com/jomdashley and consider her plea for an answer to the question that changed her life.

Together we can make a difference. Together we can find a cure.

Thank you for your time and support.
With Hope,
Christine Martin
Angel Alicia's Mom
http://www.firstgiving.com/jomdchristine

A parents plea to help fight a diffuse intrinsic pontine glioma (DIPG)

Tonight I come to you with a heavy heart and a plea. It has been 3 months since our sweet girl left our arms to be held in the arms of Jesus. She is now painfree, without limitations dancing and singing with no worries or cares. It is a beautiful vision in my mind, but it does not erase the pain and emptiness in my heart. Recently 2 other sweet innocent kids joined her Ellie Willaert and Ian Henderson. It is overwhelming to me to know that 2 more families in one day have been shattered by this dreadful tumor. But what is even more dreadful and heart wrenching is that there will be more. We have no idea why this tumor happens and we have no idea how to effectively stop it and hundreds of children will die each year because of it and hundreds of families each year will be shattered. Thousands of children and families already have been through this in the last 30 years. I don't want to see thousands of more children or families go through this in the next 30 years.

You have all been so faithful in your prayers and willing to support Ella and our family during her fight and even during our grief journey. You keep reminding us that you are here and you have not forgotten. You have shared stories with us how Ella touched you, changed you or made you a better person. Many of you follow other DIPG kids and are touched by them. Now I ask you will you help us fight? Will you help us end this tumor and end the suffering of the children and families who have and will walk in these footsteps? Will you pledge to volunteer, donate, write letters, whatever it takes to get the funding needed to stop this monster? It took me to loose my sweet little girl to know what this disease was, don't wait for that to happen to you, because it can happen to your child it can happen to anyone's child. I am proud and blessed to say that I have a group of friends who are committed to helping me do whatever it takes. To not let another Ella, go through what our Ella went through. I hope that you will join and commit also to one of the many DIPG foundations that have been started in honor of these beautiful children. I hope that you will support the Kids currently fighting DIPG in your community. I beg you to commit in some form, shape or way and show how much these kids have touched you and changed you. I am asking you for HOPE for a brighter future for kids with DIPG. In numbers there is greatness.

With tears, love and hope,
Erika
m/o Ella Hope, forever 7
http://www.caringbridge.org/visit/ellahope