The Japanese drug maker gave multiple presentations on AstraZeneca-partnered Enhertu and other deruxtecan-based ADCs. Plus Gilead presented data on Trodelvy, Amgen showed early frontline data for Lumakras, and J&J’s EGFR-directed bispecific Rybrevant showed a 50% ORR in heavily pretreated patients.

Warning letter is first issued by US FDA’s Office of Prescription Drug Promotion in more than a year and only the seventh since March 2020, continuing a trend away from using the enforcement tool. AstraZeneca asked to distribute corrective communications about pamphlet’s efficacy claims.

Efficacy in PROpel study was driven by the small percentage of patients with tumor BRCA mutations, agency says, raising concerns that olaparib may amount to a ‘toxic placebo’ in those without the mutation; Oncology Drugs Advisory Committee will consider whether new indication in metastatic castration-resistant prostate cancer should be restricted by mutation status.