Priority Review Granted in the US for Enhertu in Metastatic HER2-Positive Solid Tumors

CAR-T Digest - August 2020

29 Jan 2024: Priority Review Granted in the US for Enhertu in Metastatic HER2-Positive Solid Tumors

The application is based on results from the DESTINY-PanTumor02 trial and supported by additional Enhertu data (DESTINY-Lung01 and DESTINY-CRC02)
In the DESTINY-PanTumor02 trial, Enhertu showcased clinically meaningful survival benefits in previously treated patients with HER2-expressing metastatic solid tumors, including those in the biliary tract, bladder, cervix, endometrium, ovaries
The safety profile observed across the trials was consistent with previous clinical trials of Enhertu with no new safety concerns identified
The FDA is reviewing the submission through the Real-Time Oncology Review and Project Orbis initiatives, emphasizing international cooperation for early access to effective cancer treatments
Priority Review follows the Breakthrough Therapy Designation received in August 2023
If approved, Enhertu could offer a new treatment option for HER2-positive solid tumors, addressing an unmet need, especially for patients who have exhausted standard care options