LuciErda Erdafitinib Balversa lucius

Product Name: Erdafitinib

English Name: Erdafitinib

Drug Approval Number: 02 L 1067/24; 02 L 1068/24; 02 L 1069/24

Specifications: 3 mg × 28 tablets/box; 4 mg × 28 tablets/box; 5 mg × 28 tablets/box

Manufacturer: Lucius Pharmaceutical (Laos) Co., Ltd.

[Indications]

Erdafitinib is primarily indicated for the following conditions:

Bladder Cancer: Erdafitinib may be used to treat metastatic or recurrent bladder cancer, particularly in patients harboring *FGFR2* or *FGFR3* gene alterations.

Urothelial Carcinoma: For patients with advanced or recurrent urothelial carcinoma harboring *FGFR* gene alterations, Erdafitinib may serve as an effective treatment option.

Lung Cancer: Erdafitinib may also be utilized as a first-line treatment option for non-small cell lung cancer (NSCLC) harboring *MET* alterations.

[Dosage and Administration]

The starting dose is 8 mg taken orally once daily, either on an empty stomach or with food. For patients whose serum phosphate levels remain below the target of 5.5 mg/dL between Day 14 and Day 21, the dose should be increased to 9 mg once daily; treatment should continue until disease progression or until the medication is no longer tolerated.

If vomiting occurs after administration, do not take a replacement dose; resume the medication at the next scheduled time interval. If a dose is missed, the missed dose may be taken later on the same day; resume the medication at the next scheduled time interval.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). [Adverse Reactions]

1. The most common (≥20%) adverse reactions are:

1) Hyperphosphatemia, stomatitis, fatigue, increased creatinine

2) Diarrhea, dry mouth, onycholysis, increased ALT

3) Increased alkaline phosphatase, hyponatremia, decreased appetite, hypoalbuminemia

4) Dysgeusia, decreased hemoglobin, dry skin, increased AST

5) Hypomagnesemia, dry eye, alopecia, Hand-Foot Syndrome

6) Constipation, hypophosphatemia, abdominal pain, hypercalcemia, nausea, and musculoskeletal pain.

2. The most common (>1%) Grade 3 or higher adverse reactions are:

Stomatitis, nail dystrophy, Hand-Foot Syndrome, paronychia, nail disorders, keratitis, onycholysis, and hyperphosphatemia.

[Precautions]

1. Ocular Disorders: Erdafitinib can cause central serous retinopathy or retinal pigment epithelial detachment. Clinical symptoms manifest as blurred vision, visual floaters, or visual fatigue. The incidence rate is 25% (Grade 3: 3%), with a median time to onset of 50 days. Symptoms resolved in 13% of patients; at the clinical data cutoff, 13% of patients were still experiencing the condition. Consequently, 9% of patients required temporary interruption of erdafitinib, 14% required dose reduction, and 3% permanently discontinued erdafitinib.

2. Dry Eye: The incidence rate of dry eye is 28% (Grade 3: 6%). Use ophthalmic lubricants as needed.

3. Perform an ophthalmologic examination—including Optical Coherence Tomography (OCT)—prior to initiating erdafitinib treatment. Conduct follow-up examinations monthly for the first 4 months of treatment, and every 3 months thereafter. If visual symptoms occur, seek immediate medical attention and undergo follow-up examinations every 3 weeks until symptoms resolve.

4. Hyperphosphatemia: Serum phosphate levels exceeded the upper limit of normal in 76% of patients, with a median time to onset of 20 days. 32% of patients required the use of phosphate-lowering agents. If the patient's serum phosphate level exceeds 5.5 mg/dL, adjust the medication dosage regimen according to Tables 1 and 2.

5. Embryo-Fetal Toxicity: Animal studies have demonstrated that erdafitinib causes embryo-fetal toxicity. Patients and their partners should use effective contraception during treatment and for one month after discontinuing the medication.

[Efficacy and Safety]

The BLC2001 study was a multicenter, open-label, single-arm Phase 2 clinical trial. Eighty-seven patients with urothelial carcinoma were evaluable; the median age was 67 years, 79% were male, 74% were white, 92% had a PS score of 0–1, and 66% had metastatic disease. Ninety-seven percent of patients had received at least one prior platinum-containing chemotherapy regimen; three patients had received only neoadjuvant or adjuvant chemotherapy. Twenty-four percent of patients had received prior PD-1/L1 immunotherapy. The complete response rate was 2.3%, the partial response rate was 29.9%, the overall response rate was 32.2%, and the median duration of response was 5.4 months.

Enrolled patients all harbored at least one FGFR2/3 mutation or fusion, such as FGFR3 mutations (R248C, S249C, G370C, and Y373C), FGFR2 fusions (FGFR2-BICC1 and FGFR2-CASP7), and FGFR3 fusions (FGFR3-TACC3 and FGFR3-BAIAP2L1). For patients with FGFR3 mutations (n=64), the overall response rate was 40.6%; for those with FGFR3 fusions (n=18), the overall response rate was 11.1%; and for those with FGFR2 fusions (n=6), the overall response rate was 0%.