How Was BALVERSA Studied?

BALVERSA Clinical Study Details

BALVERSA was studied in 87 adults with advanced bladder cancer who had tried at least 1 chemotherapy

In the clinical trial for BALVERSA™, all patients had a tumor that tested positive for a certain type of abnormal FGFR gene. Everyone started on an 8-mg once-daily dose of BALVERSA™.

After about 2 weeks, all patients had a blood test to measure their phosphate levels. People with higher phosphate levels stayed at the 8-mg dose, while those with lower levels increased their dose to 9 mg once a day.

People stayed on BALVERSA™ until their tumors started to grow or until they had side effects that were too severe.

In the study, BALVERSA helped reduce the growth of tumors in patients who had an objective response

Remember, each person is different, so the results you see with BALVERSA™ may not be the same as in the study.

  • 32.2% of patients (28 out of 87) experienced a certain amount of tumor shrinkage (called an “objective response rate,” or ORR) 87 people were included in the assessment of ORR2.3% (2 out of 87) had a complete response and 29.9% (26 out of 87) had a partial response
  • Patients who had an objective response had their tumor shrinkage last for a median of 5.4 months. This means that for 50% of the patients, the response lasted for 5.4 months or longer, and for the other 50% of the patients, it was shorter than 5.4 months

See glossary for definitions of “objective response rate,” “complete response,” “partial response,” and “median.”