Exciting News! Congratulations Day One
On Tuesday, 23 April 2024, the U.S. FDA granted accelerated approval to Day One Biopharmaceuticals for tovorafenib, the first targeted therapy for relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG). As explained in Day One’s press release, “pLGG is the most common brain tumor diagnosed in children, with patients suffering profound tumor- and treatment-associated morbidities that can impact their life trajectory. BRAF is the most commonly altered gene in pLGG, with up to 75 percent of children having a BRAF alteration. Until now, there had been no medicines approved for patients with pLGG driven by BRAF fusions.”
Imaging Endpoints is immensely proud to have helped design the imaging aspects of the Study Protocol and supported image analysis for this pivotal clinical trial, underscoring our commitment to “Connecting Imaging to the Cure” [TM]. Of special interest is that accelerated approval for this tumor type was based upon Blinded Independent Central Review (BICR) analysis using RAPNO-LGG response criteria, which includes the minor responses category. To our knowledge, this may be the first marketing authorization by FDA that includes minor response as part of the approval and label.
We extend our heartfelt thanks to Day One Biopharmaceuticals for their partnership and trust. We continue to make significant strides in pediatric oncology, improving outcomes for patients worldwide.
This milestone highlights the dedication and expertise that the Imaging Endpoints’ team brings to each project, customizing the imaging design for each new trial to optimize the opportunity to demonstrate efficacy, and yielding our remarkable 95% regulatory approval rate across over 100 marketing authorizations for the registration trials we have supported.
At Imaging Endpoints, our contributions span over 550 oncology trials with zero observations from regulatory inspections, underscoring our excellence in all aspects of clinical trial imaging services.
“At Imaging Endpoints our team members work tirelessly to support our sponsors’ clinical trials in the fight against cancer, striving to help Connect Imaging to the Cure. We could not be prouder to have helped support Day One in their clinical trial and efforts leading to the FDA’s accelerated approval of tovorafenib. Day One is an incredible partner, with a passionate team dedicated to helping improve the lives of pediatric patients. We extend our sincere congratulations and gratitude to Day One for the opportunity to support them, and to the members of respective teams.” Says Ron Korn, M.D., Ph.D., Chief Medical Officer of Imaging Endpoints.
Day One Press Release for Reference: https://hubs.li/Q02vltTT0
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