JAZZ PHARMACEUTICALS FRANCE

The FDA approved PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody as a companion diagnostic for zanidatamab-hrii to assess HER2+ status in biliary tract cancer patients, identifying those eligible for zanidatamab treatment. This is the first FDA-approved companion diagnostic for HER2+ BTC, potentially improving clinical outcomes.

Mirdametinib, a MEK1/2 inhibitor, showed significant improvements in health-related quality of life (HRQOL) in adult and pediatric patients with NF1-PN in the ReNeu trial, with sustained improvements in physical, emotional, social, and school/work functioning. The trial met its primary endpoint of overall response rate (ORR) and demonstrated a manageable safety profile.

The FDA approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to assess HER2-positive status in biliary tract cancer patients, identifying those eligible for zanidatamab-hrii treatment. Zanidatamab received accelerated approval for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The phase 2b HERIZON-BTC-01 trial supported the approval, showing a 52% ORR and 14.9-month median DOR in HER2 IHC 3+ patients. Long-term follow-up data maintained cORR and DCR, with a median OS of 15.5 months. Safety data indicated common TRAEs like diarrhea and infusion-related reactions, with no deaths attributed to zanidatamab.

The FDA approved Roche’s Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, the first companion diagnostic for HER2-positive biliary tract cancer (BTC) patients eligible for treatment with Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii). This marks the first FDA-approved treatment for previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC. The test aims to improve clinical outcomes for BTC patients by providing timely, clear, and reliable results for therapeutic decisions.

Roche's PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test label expanded by FDA to include biliary tract cancer (BTC), making it the first and only FDA-approved companion diagnostic for HER2-positive BTC patients eligible for Jazz Pharmaceuticals' ZIIHERA (zanidatamab-hrii) treatment.

Jazz Pharmaceuticals' zanidatamab (Ziihera) receives US FDA accelerated approval for HER2-positive biliary tract cancer, marking the first dual HER2-targeted bispecific antibody for this indication. Based on HERIZON-BTC-01 trial data, Ziihera shows a 52% objective response rate and 14.9-month median duration of response, positioning it as an effective treatment option. The approval underscores the growing role of bispecific antibodies in cancer therapy, with sales of such antibodies projected to exceed $40 billion by 2029.

The PATHWAY HER2 (4B5) test is now the first FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer patients eligible for ZIIHERA treatment, expanding Roche's test clinical utility and offering new hope for BTC patients with limited treatment options.

The PATHWAY HER2 (4B5) test identifies HER2-positive biliary tract cancer patients eligible for ZIIHERA treatment. This FDA approval expands Roche's test indication, offering a standardized method for identifying patients who may benefit from HER2-targeted therapies, addressing a critical need in advanced BTC care.