New FIREFLY-1 Data Announced for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma
“We believe the data presented at ASCO for monotherapy tovorafenib demonstrate durable responses in children with relapsed pLGG who have limited treatment options,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Based on the strength of the safety and efficacy data we’ve observed to date, we believe tovorafenib has a compelling clinical profile. We’re looking forward to continuing our collaboration with the FDA as we submit the remainder of the data over the next several months.”
Share:
More News
“We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can address glioblastoma and other cancers. Although we are unable to provide detailed information at this stage, we are excited about the continued advancement of this important program,” said
“We are disappointed in the outcome of the RELATIVITY-098 trial and that LAG-3 inhibition in the adjuvant setting did not lead to the same improved efficacy outcomes seen in advanced melanoma,” said Jeffrey Walch, M.D., Ph.D., vice president, Opdualag global program lead, Bristol Myers Squibb. “Patients whose tumors are completely
Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas said, “The combination of enfortumab vedotin and pembrolizumab was the first approval to offer an alternative to platinum-containing chemotherapy, which had been the standard of care for first-line locally advanced or metastatic urothelial cancer for decades. We are
“U.S. FDA has accepted for review the resubmission of the BLA for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last
