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
