FDA Alignment Received on Registrational Studies Design for NDV-01 for 2L refractory high-grade NMIBC and in intermediate-risk NMIBC in the adjuvant setting
“We are very pleased with the FDA’s alignment on the registrational design for NDV-01 in high-grade BCG-unresponsive NMIBC,” said Raj S. Pruthi, MD, Chief Medical Officer – Oncology at Relmada Therapeutics. “A single-arm pivotal study in this setting represents a meaningful opportunity to advance an in-office, bladder-sparing therapy for patients who have few if any effective alternatives. This study represents the fastest path to approval for NDV-01.”
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