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.

It is a pan – fibroblast growth, factor receptor (FGFR) inhibitor.

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

Trade name Balversa.

The first targeted therapy approved for metastatic bladder cancer.

It is a selective panfibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor.

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%).

Erdafitinib therapy results in significant longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma, and FGFR alterations after previous anti-PD-1nor anti-PD – L1 treatment(THOR cohort investigators).


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