MHRA approves zanidatamab (Ziihera) for the treatment of biliary tract cancer – Jazz Pharmaceuticals

The Medicines and Healthcare products Regulatory Agency (MHRA) has  granted  approval to Jazz Pharmaceuticals Research UK Limited for  zanidatamab (Ziihera)  in adults to treat biliary tract cancer  whose cancer has high levels of a protein called HER2 and has progressed after previous treatment.  Zanidatamab is used when the cancer cannot be removed by surgery and has spread to nearby tissues or other parts of the body. Zanidatamab is administered by an infusion drip into a vein every two weeks.

The phase IIb HERIZON-BTC-01 trial (NCT04466891) in 80 patients with locally advanced or metastatic biliary tract cancer that could not be removed by surgery found that, among the 62 patients with high levels of HER2, the cancer shrank or was no longer detectable in around 52% of patients after an average follow-up of 34 months. The study did not compare Ziihera with placebo or another cancer medicine.

Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said: “Zanidatamab provides a new treatment option for adults with advanced biliary tract cancer whose disease has high levels of HER2 and has progressed following previous treatment. This approval reflects the MHRA’s commitment to ensuring patients can access safe and effective medicines where there is an unmet clinical need. As with all approved medicines, we will continue to monitor the safety and effectiveness of zanidatamab as it is used more widely.