Erdafitinib (Balversa) is an oral kinase inhibitor that was first approved in the United States in 2019. It represents a precision therapy option targeting specific genetic alterations, and is primarily indicated for the treatment of advanced urothelial carcinoma.

What Are the Indications for Erdafitinib (Balversa)?

Primary Indications

The indications for erdafitinib are highly selective, and it is not suitable for all patients with urothelial carcinoma.

Its FDA-approved indication is explicitly defined as: for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma. Two key conditions must be met simultaneously.

Presence of specific genetic alterations: The patient's tumor must harbor susceptible FGFR3 or FGFR2 gene mutations or fusions. This is a prerequisite for initiating treatment, which must be confirmed in tumor samples via an FDA-approved companion diagnostic test.

Prior treatment history: The patient's disease has progressed during or following platinum-containing chemotherapy. This includes disease progression after receiving at least one line of platinum-containing chemotherapy (e.g., cisplatin or carboplatin), as well as disease progression occurring within 12 months after neoadjuvant or adjuvant platinum-containing chemotherapy.

Dosage Forms and Characteristics of Erdafitinib (Balversa)

Dosage Forms (Dose Strength)

3 mg tablet: Yellow, round, biconvex, film-coated tablet. One side is engraved with "3" and the other side with "EF".

4 mg tablet: Orange, round, biconvex, film-coated tablet. One side is engraved with "4" and the other side with "EF".

5 mg tablet: Brown, round, biconvex, film-coated tablet. One side is engraved with "5" and the other side with "EF".

Characteristics

The film-coating layer of the tablets contains glyceryl monocaprylocaprate Type I, partially hydrolyzed polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide, yellow iron oxide, and other ingredients.

Additionally, the orange and brown tablets contain red iron oxide, and the brown tablets further contain iron oxide black (ferroferric oxide).

The tablet core contains croscarmellose sodium, magnesium stearate (of plant origin), mannitol, meglumine, and microcrystalline cellulose.

Storage Method for Erdafitinib (Balversa)

Storage Conditions

This product should be stored at room temperature between 20°C and 25°C (68°F and 77°F).

Short-term storage and transportation are permitted within a temperature range of 15°C to 30°C (59°F to 86°F).

Do not freeze. The drug should be kept in its original packaging, stored in a dry place, and always kept out of the reach of children.