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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.

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.

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