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

“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,

“We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor

“These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform” said Namir Hassan, Chief Executive Officer of Zelluna. “The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose

“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us