505(b)(2) NDA for Lutetium Lu 177 Dotatate Injection submitted to the FDA for the treatment of somatostatin receptor-positive GEP-NETS
Michael Patterson, Curium North America CEO commented: “Curium’s 505(b)(2) new drug application for Lutetium Lu 177 Dotatate Injection marks another important milestone for Curium in its evolution to bring new tools for patients and healthcare providers to both diagnose and now potentially treat disease. Nuclear medicine-based cancer therapies must continue to be more widely and reliably available for patients and their caregivers.”
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
