News & Blog

Creating a Better Path for Brain Tumor Drug Approval

At the end of summer we told you all about a new initiative of the National Brain Tumor Society called the Clinical Trial Endpoints Initiative, which aims to jumpstart brain tumor treatment development.

At the time we were just getting back from an extremely fruitful meeting with the U.S. Food & Drug Administration (FDA), which set the stage for two upcoming workshops with representatives from the FDA, other brain tumor nonprofits and organizations, prominent neuro-oncologists, and executives from the biopharmaceutical industry.

The purpose of these meetings is to jointly develop, with the buy-in of all of the critical parties (clinicians, researchers, biopharma and the FDA), better measures (“endpoints”) and pathways for the evaluation and approval of potential brain tumor therapies. The hope is that, with a more favorable and well-defined regulatory environment, more biotech and pharmaceutical companies will begin to invest in brain tumor drug development; thus opening a new pipeline for treatments that can help patients.

I’ll let Dr. Patrick Wen, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, and Chair of our Clinical Trial Endpoints steering committee, explain more:

We will have a lot more on this initiative in the next few months, including ways you can help inform the neuro-oncology about treatments that matter to you.

1 Comment

  • Rhonda says:

    As a nurse for 28 years I wholehearted understand the need for clinical trials using placebos or 2nd arm . Those diagnosed with Glioblastoma Multiforme Brain Cancer, they should be offered any trial with potential in the state they live in since not only their quality of life is very short but life itself approx 14.6 months. They deserve to spend that time with their families, not in travel ; gambling whether they will actually come back home to their family or not. This Brain Cancer needs to be placed on the Front burner! Instead of giving empty hope, give a true possibly with the clinical trial showing the best outcome yet. These precious patients will grasp at anything for more time, including leaving their family not knowing how fast the clock is ticking. I Feel After Diagnosis A Lumbar Puncture should be done to check for cells in the spinal fluid. First not later! I feel some research needs to focus more on the cause to find what the “Specific patients GBM is resistant or non- resistant to. How to place this Cancer in remission or to slow the rate of regrowth down. When there is a trial being used and is effective for a patient, there should be no question that there is not enough to see that patient through, and for more patients to whom may benefit from that same trial. We as medical professionals should not lose a patient due to lack of the drug sustaining their life.
    GBM, Stage 4 , Astrocytoma whatever you want to call it, is NOT RARE! The only thing Rare is the lack of knowledge known amongst the medical community! SAD! A money maker from the ER to the funeral home! This is completely unexceptable!

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