14/09/2026 US FDA reduces IMDELLTRA monitoring time to 6–8 hours, expanding Community Oncology Access BioNTech & Onco4's gotistobart doubled mOS vs docetaxel in non-pivotal part of the Ph3 PRESERVE-003 trial US FDA grants Breakthrough Therapy Designation to RASONQUE™ (daraxonrasib) + chemotherapy for first‑line metastatic pancreatic cancer In the Ph3 DESTINY-Lung04 trial, trastuzumab deruxtecan improved median PFS by 6 months vs pembro + chemo, in 1L HER2-mutant NSCLC pts Pos

26/02/2026 Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC Izalontamab brengitecan elicited significant PFS and OS benefit in TNBC Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC (Ref) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for an expanded indication for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutat

05/02/2026 Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma (Ref) The US FDA granted the orphan drug designation to Partner Therapeutics' zenocutuzumab‑zbco (HER2xHER3 bispecific antibody) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma. Zenocutuzumab is being developed in a subset of pa

10/11/2025 Boehringer Ingelheim's zongertinib received the Commissioner’s National Priority Voucher for HER2-mutant NSCLC (Ref) The US FDA awarded a Commissioner’s National Priority Voucher (CNPV) to Boehringer Ingelheim's zongertinib (HER2 TKI) for the treatment of patients with HER2-mutant NSCLC. Boehringer Ingelheim is planning a sNDA for zongertinib in the first-line treatment of patients with HER2-mutant NSCLC Previously, zongertinib received accelerated approval by the