European Commission approves BALVERSA (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma

“This important milestone emphasises the vital role of targeted therapies in addressing the unique genetic and disease characteristics of patients living with urothelial cancer, and reinforces our dedication to advancing cutting-edge, precision treatments in oncology,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “The approval of erdafitinib as a precision therapy further highlights the importance of FGFR testing for all patients with metastatic urothelial cancer, and the need for a multi-disciplinary team approach to optimise outcomes for each patient.”

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