Approved for the treatment of adult patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy.

Trade name Balversa.

The first targeted therapy approved for metastatic bladder cancer.

FGFR3 alterations a present in 10-20% of muscle invasive bladder cancers and 40-50% of upper tract  urothelial carcinomas.

The approval is based on the phase II BLC2001 trial, in which the drug induced an overall response rate of 32.2% in patients with FGFR2/FGFR3-positive locally advanced or metastatic bladder cancer.

The ORR comprised a complete response rate of 2.3% and a partial response rate of 29.9%.

Responders included patients who had been unresponsive to anti–PD-1/PD-L1 treatment.

A companion diagnostic device should be used in patient selection for erdafitinib.

The QIAGEN therascreen® FGFR RGQ Reverse-transcription (RT)-polymerase chain reaction (PCR) Kit has been approved as a companion diagnostic for use with erdafitinib.

The starting dose of erdafitinib was 8 mg once daily.

Patients whose serum phosphate levels were below the target of 5.5 mg/dL between days 14 and 17 had their dose increased to 9 mg once daily.

The median duration of response was 5.4 months.

Among 64 patients with an FGFR3 point mutation, the ORR was 40.6% and the ORR was 11.1% among 18 patients with an FGFR3 fusion.

There were no confirmed responses among the 6 patients with an FGFR2 fusion.

The most common adverse events: were phosphate increased (76%), stomatitis (56%), fatigue (54%), creatinine increased (52%), diarrhea (47%), dry mouth (45%), onycholysis (41%), ALT increased (41%), ALP increased (41%), sodium decreased (40%), decreased appetite (38%), albumin decreased (37%), dysgeusia (37%), hemoglobin decreased (35%), dry skin (34%), AST increased (30%), magnesium decreased (30%), dry eye (28%), alopecia (26%), palmar-plantar erythrodysesthesia syndrome (26%), constipation (28%), phosphate decreased (24%), abdominal pain (23%), calcium increased (22%), nausea (21%), and musculoskeletal pain (20%).

Grade ≥3 AEs that were the most common included onycholysis (10%), stomatitis (9%), palmar-plantar erythrodysesthesia syndrome (6%), and paronychia (3%).

FGFRs regulate important biological processes including cell growth and division during development and tissue repair.

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