How FDA-Authorised Modeyso Works to Deal with Glioma

The U.S. Meals and Drug Administration (FDA) not too long ago granted accelerated approval to Modeyso (dordaviprone) for the remedy of sufferers with diffuse midline glioma (a kind of mind most cancers) with an H3 K27M mutation.

Following the issuance of this approval, CURE sat down for an interview with Dr. Patrick Wen, director of the Heart for Neuro-Oncology at Dana-Farber Most cancers Institute and professor of Neurology at Harvard Medical College in Boston. Wen was the senior writer of a research printed within the Journal of Medical Oncology that discovered monotherapy with Modeyso to be well-tolerated, with sturdy and clinically significant effectiveness amongst sufferers with recurrent H3 K27M-mutant diffuse midline glioma.

The accelerated approval is for the remedy of grownup and pediatric sufferers aged one yr and older with diffuse midline glioma harboring an H3 K27M mutation and progressive illness following prior remedy. It’s, based on the regulatory company, the primary FDA-approved systemic remedy for H3 K27M-mutant diffuse midline glioma.

Wen spoke with CURE about how Modeyso works to deal with glioma and, now that this remedy choice is out there, what unmet wants nonetheless stay for sufferers.

Transcript

How does Modeyso work to deal with glioma, and now that it’s accessible, what unmet wants stay for sufferers?

It is thought to work in two methods. One is that it blocks some receptors, the dopamine receptors two and three. By blocking it, it slows down tumor development. It additionally stimulates a distinct receptor that impacts the metabolism of the tumor cells, and by doing so, causes the tumor cells to bear adjustments that make it extra more likely to die. So, that is by stimulating one thing referred to as ClpP and mitochondria.

Each these mechanisms are considered in play. It is not totally clear which one is the extra essential one.

It was based mostly on the research for measurable illness. It is primarily thalamic gliomas, that are greater up within the mind stem. We do not have as a lot details about the effectiveness for the diffuse intrinsic pontine glioma, that are the actually devastating tumors in youngsters.

It is actually for the thalamic sickness that this remedy is useful. Hopefully will probably be considerably useful for the DIPGs additionally, however we do not have as a lot data.

Transcript has been edited for readability and conciseness.

References

1. “FDA grants accelerated approval to dordaviprone for diffuse midline glioma,” by the U.S. FDA. Information launch; Aug. 6., 2025. https://www.fda.gov/medicine/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma
2. “ONC201 (Dordaviprone) in Recurrent H3 K27M-Mutant Diffuse Midline Glioma,” by Dr. Isabel Arrillaga-Romany, et al. The Journal of Medical Oncology. Might 1, 2024.
3. “FDA Approval of Modeyso ‘Vital Step Ahead’ For Sufferers with Glioma,” by Dr. Patrick Wen. CURE; Aug. 15, 2025; https://www.curetoday.com/view/fda-approval-of-modeyso-important-step-forward-for-patients-with-glioma
4. “FDA Approves Modeyso for Sufferers with Diffuse Midline Glioma,” by Alex Biese. CURE; Aug. 6, 2025; https://www.curetoday.com/view/fda-approves-modeyso-for-patients-with-diffuse-midline-glioma

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