NDA for Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma to be submitted Before Year-End
“We expect that, if approved, dordaviprone will fundamentally change the treatment landscape for patients suffering from this lethal form of brain cancer who have extremely limited treatment options. We have worked collaboratively with the U.S. FDA, disease experts and patient advocates throughout the year to potentially accelerate access to dordaviprone for this patient community,” said Mike Andriole, Chief Executive Officer of Chimerix. “In anticipation of a potential approval, we have bolstered our commercial leadership team and will be ready for a U.S. launch as early as the third quarter of 2025, pending application acceptance and Priority Review, if granted.”
Share:
More News
“Fast Track designation in lung cancer represents an important milestone for TRE-515 and further validates our strategy of combining dCK inhibition with targeted cancer therapies,” said Dr. Ken Schultz, Trethera Chairman and CEO. “KRAS G12C inhibitors have transformed the NSCLC treatment landscape, but resistance and incomplete responses remain major challenges.
“AvenCell has built a differentiated cell therapy platform that brings together CRISPR-engineered allogeneic CAR-T technology with a unique switchable CAR approach designed to provide greater control over CAR-T activity,” said Todd Davis, CEO of Ligand. “We believe the combination of these technologies, together with the encouraging clinical data generated to
“Advanced gastric cancer is characterized by substantial biological and clinical heterogeneity. Previous studies have shown that the magnitude of benefit from PD-1 inhibitor therapy is closely associated with PD-L1 expression, and that there remains room to further improve outcomes, particularly in patients with low PD-L1 expression. How to broaden the
“The evERA results represent an important step forward for people with ER-positive advanced breast cancer and underscore the potential for giredestrant to help address the challenge of disease progression in this setting,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Together with the