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Balversa (erdafitinib)

Balversa (erdafitinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.1 It is recommended for use in select cases that have:

  • Susceptible fibroblast growth factor receptor FGFR3 or FGFR2 genetic alterations, and
  • Progressed during or following at least one line of prior platinum-containing chemotherapy including within 1 year of neoadjuvant or adjuvant platinum-containing chemotherapy.

Bladder cancer is the 6th most common type of cancer in the United States. Erdafitinib, a product of Janssen Pharmaceutical Company, a division of Johnson & Johnson, received a breakthrough therapy designation for metastatic urothelial bladder cancer. A Breakthrough Therapy Designation may be granted if there is preliminary clinical evidence that demonstrates the drug may result in the substantial improvement of at least one clinically significant endpoint over currently available therapy.2,3 There have been limited treatment options for this type of bladder cancer.

Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor. FGFRs are a family of receptor tyrosine kinases which may be upregulated, increasing the response in certain tumor cell types and may be involved in tumor cell differentiation and proliferation (increase in the number of cells), tumor angiogenesis (the vascularization of the tumor), and tumor cell survival.1

How does erdafitinib work?

FGFR, fibroblast growth factor receptors, are thought to have a role in cancer growth and development in some types of cancer cells. Erdafitinib, an FGFR kinase inhibitor, blocks the action of FGFR. This could slow down or stop tumor cells dependent on this growth factor to replicate. Around 20% of recurring or refractory bladder cancers have the FGFR mutation which may respond to treatment with an FGFR inhibitor.1,4

What are the possible side effects of erdafitinib?

The most common side effects of erdafitinib include:1

  • Fatigue
  • Change in kidney or liver function
  • Constipation or diarrhea
  • Dry mouth and/or mouth sores
  • Stomach pain, nausea, decreased appetite
  • Increased levels of phosphate or decreased levels of sodium in the blood
  • Changes in nail appearance
  • Dry skin, dry eyes
  • Low red blood cell counts (anemia)
  • Hair loss
  • Muscle pain
  • Hand-foot syndrome: the swelling, peeling, redness, or tenderness of the hands and feet

Erdafitinib can cause harm to a developing fetus and should not be taken by women who are pregnant. While taking erdafitinib men and women should both use contraceptives for a month after completing treatment. Women currently breastfeeding should not take erdafitinib.

This is not an exhaustive list of all potential side effects of erdafitinib. Talk to your healthcare provider or pharmacist for further information.

Things to know about Erdafitinib

Erdafitinib is the first FGFR kinase inhibitor to receive US FDA approval.3 When the FDA approved erdafitinib, it simultaneously approved a companion diagnostic tool to help identify the subgroup of people most likely to benefit from the drug. That’s designed to create a more personalized treatment approach.3

The diagnostic kit is QIAGEN therascreen®. It detects the presence of FGFR in tumor tissue of people with metastatic urothelial cancer. If present, the patient may be a candidate for treatment with erdafitinib.1,3,4

Erdafitinib can cause ocular disorders (problems with your eyes), including central serous retinopathy (CSR) that’s characterized by retinal pigment epithelial detachment (RPED) resulting in visual field defects.1,3 Monthly eye exams should be performed during the first 4 months of treatment with erdafitinib, and every 3 months afterward. Eye exams should include evaluation of visual acuity- how well you see at various distances, a slit lamp examination- a microscope with a bright light used to look at different structures at the front of and inside the eye and inside the eye, fundoscopy- a magnifying lens and light used to examine the fundus of the eye including the back of the inside of the eye, the retina and optic nerve, and OCT optical coherence tomography- a non-invasive diagnostic technique to look at the retina. Talk to your healthcare provider immediately if you notice changes in vision.

Erdafitinib can also cause hyperphosphatemia, an abnormally high serum phosphate concentration (greater than 4.5 mg/dL). It can be caused by increased phosphate intake, decreased phosphate excretion, or associated with an underlying disease such as bladder cancer that can have increased phosphate values.1

Dosing information

Prior to initiating treatment, the presence of FGFR genetic alterations in tumor specimens should be confirmed. Erdafitinib comes in tablet form in 3 mg (yellow), 4 mg (orange), and 5 mg (brown) strengths. The tablets should be swallowed whole with or without food.1

Should adverse reactions be experienced, your physician can make dose modifications resulting in an interruption, reduction or discontinuation of erdafitinib.

If vomiting occurs any time after taking erdafitinib, take the next dose on the next day. Treatment should continue until disease progression or unacceptable toxicity levels occurs. If you miss a dose of erdafitinib, take it as soon as possible on the same day. Follow the regular daily dose schedule the next day. Do not take extra medication to make up for a missed dose.1

Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their erdafitinib regimen.

For more details, read the full prescribing information of erdafitinib.

Written by Linda Minton | Last review date: July 2019.
  1. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212018s000lbl.pdf. Accessed 6.12.19
  2. Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer Available at: https://www.jnj.com/media-center/press-releases/janssen-announces-us-fda-breakthrough-therapy-designation-for-erdafitinib-in-the-treatment-of-metastatic-urothelial-cancer. Accessed 6.12.19.
  3. BALVERSA™ (erdafitinib) Receives U.S. FDA Approval for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alterations Available at: https://www.jnj.com/balversa-erdafitinib-receives-u-s-fda-approval-for-the-treatment-of-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-with-certain-fgfr-genetic-alterations. Accessed 6.12.19.
  4. First Targeted Therapy for Metastatic Bladder Cancer Approved by FDA. Available at: https://bladdercancer.net/news/targeted-therapy-balversa/. Accessed 6.12.19.