FDA Orphan Drug Designation for CTD402 for the Treatment of T-Cell Leukemia and Lymphoma
“Receiving orphan drug designation for CTD402 is an important milestone for patients with relapsed or refractory T‑ALL/LBL, who urgently need more effective and accessible treatment options,” said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, M.D., Ph.D. “This recognition provides regulatory support and extended market exclusivity to advance our development pathway, supporting our belief that a truly off‑the‑shelf CAR‑T therapy, available at the point of care, has the potential to change the treatment paradigm for these rapidly progressing diseases.”
Share:
More News
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated
“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with
“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines