Enhertu approved for use before surgery based on DESTINY-Breast11 Ph 3 trial and following surgery based on DESTINY-Breast05 Ph 3 trial in HER2-positive early breast cancer

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “HER2-positive early disease is considered highly curable, however up to one in four patients still experience disease recurrence, underscoring the need for new options in this setting. These approvals mark an important step forward, expanding the possibility of cure to more patients for the first time in many years and positioning Enhertu as a foundational treatment in early breast cancer.”

Share:

More News

“Checkpoint inhibitors have transformed the treatment landscape in many cancers. Unfortunately, the vast majority of colorectal cancer patients with liver metastases remain without an effective immunotherapy option. The liver is a critical immunological bottleneck – a site where anti-tumor immunity is actively suppressed, blunting the benefit of checkpoint blockade,” said

“The ARASEC trial was designed to further evaluate NUBEQA plus ADT in patients with metastatic castration-sensitive prostate cancer using a rigorous and innovative study approach,” said Yesmean Wahdan, Senior Vice President and Head of Medical Affairs, U.S. and North America Pharmaceuticals at Bayer. “Supported by our robust clinical development program,

The sNDA is based on results from the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15). In EV-304, neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab was compared with standard-of-care neoadjuvant gemcitabine and cisplatin chemotherapy in MIBC patients eligible for cisplatin-containing chemotherapy. In the Event-Free Survival (EFS) analysis, enfortumab vedotin

“CREATE was built as an iterative immune programming platform in which each clinical study informs and strengthens the next, and it is that work that has revealed the breadth of what in vivo immune programming can address,” said Daniel Getts, PhD, Chief Executive Officer of CREATE Medicines. “Our autoimmune and