FDA Approves Balversa for Metastatic Bladder Cancer

The FDA approved Balversa for some patients with locally advanced or metastatic bladder cancer.

The Food and Drug Administration (FDA) approved Balversa (erdafitinib) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved test. To be eligible for the therapy, patients must have experienced disease progression on or after one or more prior therapy, according to the FDA.

The drug is not intended for patients who are eligible for, but have not yet received PD-1 or PD-L1 inhibition therapy.

Additionally, this approval amends the indication that was previously granted accelerated approval for patients with metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 alterations that had previous platinum-containing chemotherapy.

This approval is based on findings from Study BLC3001 Cohort 1, a randomized trial of 266 patients with metastatic bladder cancer that has selected FGFR3 alternations and received one or two prior systemic treatments, including a PD-1 or PD-L1 inhibitor.

Patients in the trial were randomly assigned to receive Balversa or investigator’s choice of chemotherapy (either docetaxel or vinflunine). Participants were distributed based on region, performance status (how independently they can perform their daily tasks) and presence of visceral or bone metastases.

FGFR3 alterations were identified from tumor tissue by the therascreen FGFR RGQ RT-PCR kit (Qiagen) in 75% of patients, while the remainder were identified by local next-generation sequencing assays.

The main goal of the trial was overall survival (time from treatment until death of any cause). The researchers also analyzed progression-free survival (time patients live after treatment without their disease worsening) and objective response rate (percentage of patients whose disease shrinks or disappears from treatment).

Findings showed that Balversa bested chemotherapy regarding median overall survival (12.1 months in the Balversa group compared with 7.8 months in the chemotherapy group), progression-free survival (5.6 months compared with 2.7 months, respectively) and objective response rate (35.3% compared with 8.5%, respectively).

The most common side effects that occurred in 20% or more of patients, including laboratory abnormalities, were: increased phosphate (which could indicate kidney damage), nail disorders, diarrhea, stomatitis, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, decreased sodium, increased creatinine, dry mouth, decreased phosphate, hand-foot syndrome, foul or metallic taste in the mouth, fatigue, dry skin, constipation, decreased appetite, increased calcium, hair loss, dry eye, increased potassium and decreased weight.

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