Updated data from the Phase II EV-201 study of Seattle Genetics/Astellas Pharma’s novel ADC are strong enough to warrant accelerated approval, its investigators claim. An accelerated submission to the US FDA is due later this year.
Updated data from the first cohort of the Phase II EV-201 study of Seattle Genetics Inc./Astellas Pharma Inc.’s antibody-drug conjugate enfortumab vedotin continue to impress, with a confirmed 44% objective response rate and a median survival time of 11.7 months in a heavily pre-treated advanced urothelial cancer population.
Principal investigator Daniel Petrylak at Yale Cancer Center, who presented at the American Society of Clinical Oncology meeting in Chicago...
Iovance’s Amtagvi won FDA accelerated approval in February, and Adaptimmune’s afami-cel may not be far behind, but cell therapies for solid tumors come with some extra challenges.
The discussant at ASCO’s NSCLC session said the field would need to “manage expectations” as the drugs do not appear to beat chemotherapy in all-comers.
Scrip reporter Alaric DeArment is joined by the Datamonitor Healthcare oncology analysts to review key highlights from the recent American Society of Clinical Oncology annual meeting.
US-based Citeline writer Sarah Karlin-Smith joins Brian Yang and Dexter Yan in China to discuss the US BIOSECURE Act and the recent BIO meeting in San Diego, while Dexter Yan discusses China-related ASCO highlights, in this mixed Chinese- and English-language episode.
AstraZeneca’s NIAGARA trial of perioperative Imfinzi in bladder cancer was positively received at the ESMO meeting but its design did not distinguish the contributions of each treatment portion to the overall effect – something that the US FDA is likely to have a view on.
Persistence has paid off for Incyte’s Zynyz in anal cancer with a Phase III win that should make up for a previous disappointment at the FDA and give a boost to the firm’s pipeline prospects for a post-Jakafi era.
Sutro Biopharma CEO Bill Newell spoke with Scrip about the company’s novel platform, its goal of improving folate receptor alpha-driven ovarian cancer and its business development strategy.
