FDA clears IND Application for 225Ac-FL-020 for the Treatment of mCRPC

“The IND application clearance is a significant regulatory milestone in our development plan for 225Ac-FL-020”, said Steffen Heeger, M.D., M.Sc., Chief Medical Officer of Full-Life. “This important step underscores our overall commitment to the therapeutic potential of radiopharmaceuticals and once again highlights the value of the team´s effort, dedication, and cross-functional collaboration. We are excited to initiate the Phase I clinical program, which provides the first opportunity to gather human data on 225Ac-FL-020’s safety and anti-tumor activity.”
Share:
More News
“KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved,
“We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to
“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look
“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are