Shots:
- The EC has granted conditional approval to Ziihera in 30 EEA states for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) BTC adults, who were previously treated with ≥1L of therapy
- Approval was based on P-IIb (HERIZON-BTC-01) trial assessing Ziihera in 87 pts, where Arm 1 (n=80: 18 had IHC 2+ tumors & 62 had IHC 3+ tumors) achieved cORR (1EP) of 41.3% incl. 2 CR at mFU of 21.9mos., with mDoR of 14.9mos. & mOS of 15.5mos. In IHC 3+ tumor pts, cORR was 51.6%, with mDoR of 14.9mos. & mOS of 18.1mos.
- Ziihera’s continued approval depends on confirmation of clinical benefit in the ongoing P-III (HERIZON-BTC-302) trial assessing it with SoC vs SoC alone in 1L HER2+ BTC pts
Ref: PRNewswire | Image: Jazz Pharmaceuticals | Press Release
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