XTANDI (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting
Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas: “This expanded approval for XTANDI is a vitally important advance for patients with nmHSPC with high-risk BCR and is a testament to our long and ongoing collaboration with a global network of dedicated clinical trial investigators, patient groups, clinical trial participants and their families. Efficacy and safety results from the EMBARK study demonstrate the potential for XTANDI as a new option for treatment in the early, recurrent hormone-sensitive prostate cancer setting. Astellas is in active discussions with regulatory authorities around the world to bring XTANDI to those who may benefit.”
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
