Shots:
The P-III (HERIZON-GEA-01) trial assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as the 1L treatment in 914 adults with HER2+ locally advanced or metastatic GEA
Ziihera + CT & Ziihera + Tevimbra + CT showed prolonged PFS with 35% risk reduction delivering mPFS of 12.4mos., with mOS of 24.4 & 26.4mos., respectively,…
Shots:
Jazz Pharmaceuticals and partners presented seven abstracts from their oncology development program at ASCO 2025Â
 Robert Iannone, CMO, EVP, Global Head of Research and Development, and Chief Medical Officer at Jazz Pharmaceuticals, in an engaging discussion with PharmaShots, shared four-year follow-up data from an ongoing P-II trial of Ziihera in combination with CT for…
Shots:
PharmaShots has compiled a list of US FDA-approved drugs in the month of November 2024
The US FDA has approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry
The major highlighted drug was Jazz Pharmaceuticals’ Ziihera…
Shots:
The US FDA’s accelerated approval of Ziihera (50mg/mL, IV) was based on P-IIb (HERIZON-BTC-01) study in patients (n=87) with HER2+, locally advanced unresectable or metastatic BTC across 2 arms, based on tumor IHC status
Efficacy in 62 HER2+ BTC patients (arm 1 of HERIZON-BTC-01) showed a 52% ORR & 14.9mos. mDoR. Continued approval depends…

