NEW YORK – Shanghai-based Zai Lab said this week that the Center for Drug Evaluation within China's National Medical Products Administration has granted breakthrough therapy designation to bemarituzumab plus chemotherapy as a first-line treatment for patients with FGFR2b-overexpressing, HER2-negative advanced gastric or gastroesophageal junction cancer. The CDE prioritizes communications with sponsors of breakthrough therapies and provides guidance through the drug development process. The regulators awarded the designation based on the Phase II FIGHT trial, in which patients on bemarituzumab and chemo had significantly better progression-free survival, overall survival, and objective response rates compared to those on just chemotherapy.
Zai Lab, which has an exclusive license to develop and commercialize bemarituzumab in greater China, collaborated on the FIGHT trial with Amgen subsidiary Five Prime Therapeutics. Amgen will begin a registrational program in Q4 2021 for bemarituzumab, which also has breakthrough therapy designation from the US Food and Drug Administration for the same indication.
Roche said this week it has launched the Digital Pathology Open Environment, which allows software developers to integrate their image analysis tools for tumor tissue with Roche's uPath software for pathologist workflow. The open environment allows for the secure exchange of data so pathologists can access algorithms from third parties in addition to Roche's menu of artificial intelligence-based image analysis tools, the company said. Global software developers are also able to distribute their digital products through Roche’s software.
Konica Minolta Precision Medicine said this week it is changing its name to Realm IDx to reflect its focus on integrated diagnostics, which brings together genomics, radiology, pathology, and artificial intelligence. Realm IDx aims to provide insights for the prediction, diagnosis, and treatment of disease. The firm is a subsidiary of Konica Minolta.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.