(Reuters) -The U.S. Food and Drug Administration approved Jazz Pharmaceuticals’ drug for the treatment of a type of biliary tract cancer, the company said on Wednesday. The drug zanidatamab-hrii, sold under the brand name Ziihera, is approved for use in previously treated adults with metastatic HER2-positive biliary tract cancer. HER2 is a protein that stimulates quick growth of cancer cells. Its presence in solid tumor form includes biliary tra…

WTVB

Jazz Pharmaceuticals receives FDA approval for biliary tract cancer treatment

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Midwest Communications

Jazz Pharmaceuticals secures FDA approval for Ziihera, the first dual HER2-targeted therapy for biliary tract cancer, showing promising 14.9-month response duration.

stocktitan.net

Jazz Pharma's Ziihera Wins FDA Approval with 52% Response Rate in Cancer Trial

(Reuters) –     The U.S. Food and Drug Administration approved Jazz Pharmaceuticals’ drug, zanidatamab-hrii, for the treatment of a type of biliary tract cancer, the company said on Wednesday. The drug, sold under the brand name Ziihera, is approved for use in previously treated adults with metastatic HER2-positive biliary tract cancer. HER2 is a protein that stimulates quick growth of cancer cells. Its presence in solid tumor form includes bili…

regionalmedianews.com

Jazz Pharmaceuticals receives FDA approval for biliary tract cancer treatment - Regional Media News

The FDA granted an accelerated approval to zanidatamab-hrii for previously treated, unresectable or metastatic HER2-positve biliary tract cancer.

onclive.com

FDA Approves Zanidatamab for Pretreated HER2-Positive Biliary Tract Cancer

Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S. Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial Company to host investor webcast on Dec. 11, 2024 For U.S. media and investors only  DUBLIN, Nov. 20, 2024 /PRNews…

The AI Journal

Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)

Results from the HERIZON-BTC-01 trial led to the approval of zanidatamab for patients with metastatic HER2-positive biliary tract cancer.

cancernetwork.com

FDA OKs Zanidatamab Injection for Metastatic HER2+ Biliary Tract Cancer

Produced in Chinese hamster ovary cells, Ziihera (zanidatamab-hrii) is the first HER2-targeted bispecific antibody treatment for patients with previously treated, unresectable or metastatic biliary tract cancer.

Managed Healthcare Executive

FDA Approves Biliary Tract Cancer Antibody Treatment

The agency has approved Ziihera for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer.

Jazz Pharmaceuticals receives FDA approval for biliary tract cancer treatment

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