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Erdafitinib

Erdafitinib is an innovative drug being studied in clinical trials for various types of cancer. It works by targeting specific genetic alterations in fibroblast growth factor receptors (FGFR), which play a role in cancer growth. This article explores the ongoing research into erdafitinib’s potential as a treatment for cancers including bladder cancer, lung cancer, and other solid tumors with FGFR alterations.

Table of Contents

What is Erdafitinib?

Erdafitinib is a medication used to treat certain types of cancer. It is also known by the brand name Balversa and the research code JNJ-42756493[1][2]. Erdafitinib is a type of drug called a tyrosine kinase inhibitor, which means it works by blocking specific proteins that help cancer cells grow[3].

How Does Erdafitinib Work?

Erdafitinib specifically targets proteins called fibroblast growth factor receptors (FGFRs). These proteins are involved in cell growth and division. In some cancers, FGFRs can be altered or overactive, leading to uncontrolled cell growth. Erdafitinib works by blocking these altered FGFRs, which may help slow or stop cancer growth[4].

What Conditions Does Erdafitinib Treat?

Erdafitinib is primarily used to treat certain types of cancer that have specific genetic alterations in the FGFR genes. These include:

  • Bladder cancer: Erdafitinib is approved by the FDA for treating advanced bladder cancer (also called urothelial cancer) with FGFR alterations[3].
  • Non-small cell lung cancer (NSCLC): Research is ongoing to evaluate erdafitinib’s effectiveness in treating NSCLC with FGFR alterations[4].
  • Other solid tumors: Studies are investigating erdafitinib’s potential in treating various other cancers with FGFR alterations, including cholangiocarcinoma (bile duct cancer), esophageal cancer, and ovarian cancer[5][3].

How is Erdafitinib Given?

Erdafitinib is taken orally as a tablet. The typical starting dose is 8 milligrams (mg) once daily, which may be increased to 9 mg daily based on how well it’s tolerated and its effectiveness[1]. Your doctor will determine the right dose for you and may adjust it based on your response to the treatment and any side effects you experience.

Ongoing Research

Several clinical trials are currently investigating erdafitinib’s potential in various situations:

  • Combination therapy: Researchers are studying how erdafitinib works when combined with other cancer treatments, such as immunotherapy drugs like cetrelimab[6].
  • Earlier stage cancers: Some studies are looking at using erdafitinib before surgery (neoadjuvant treatment) in muscle-invasive bladder cancer[6].
  • Rare cancers: Erdafitinib is being studied in uncommon cancers like steroid cell tumors of the ovary[3].
  • Pediatric cancers: Research is ongoing to evaluate erdafitinib’s safety and effectiveness in children and adolescents with solid tumors that have FGFR alterations[2].

Side Effects

Like all medications, erdafitinib can cause side effects. Common side effects may include:

  • Mouth sores (stomatitis)
  • Low sodium levels in the blood (hyponatremia)
  • Eye problems
  • Skin reactions
  • Diarrhea
  • Fatigue

Your healthcare team will monitor you closely for side effects and can help manage them if they occur. It’s important to report any new symptoms or changes in your health to your doctor[1][3].

Aspect Details
Drug Name Erdafitinib (also known as JNJ-42756493)
Drug Class Tyrosine kinase inhibitor, specifically targeting FGFR1-4
Administration Oral tablet, typically 8 mg once daily, may be increased to 9 mg
Cancer Types Studied Bladder cancer, non-small cell lung cancer, cholangiocarcinoma, other solid tumors with FGFR alterations
Key Eligibility Criteria Presence of specific FGFR genetic alterations in tumor
Primary Outcomes Measured Objective response rate, progression-free survival, safety and tolerability
Notable Side Effects Changes in phosphate levels, mouth sores, fatigue, vision changes
Current Status In various phases of clinical trials; approved for some indications in certain countries

FAQ

  • What is erdafitinib? Erdafitinib is a type of drug called a tyrosine kinase inhibitor. It works by blocking proteins called fibroblast growth factor receptors (FGFR) that are involved in cancer growth. Erdafitinib is being studied as a treatment for cancers that have certain genetic changes in FGFR genes.
  • What types of cancer is erdafitinib being studied for? Clinical trials are investigating erdafitinib for several cancer types, including bladder cancer, non-small cell lung cancer, cholangiocarcinoma (bile duct cancer), and other solid tumors that have FGFR genetic alterations.
  • How is erdafitinib given to patients? Erdafitinib is taken orally as a tablet, usually once daily. The typical starting dose is 8 mg per day, which may be increased to 9 mg based on how well it is tolerated and its effects on blood phosphate levels.
  • What are the potential side effects of erdafitinib? Common side effects may include mouth sores, changes in blood phosphate levels, fatigue, and changes in vision. More serious side effects are possible. The trials are closely monitoring patients for any adverse events.
  • How do I know if I'm eligible for an erdafitinib clinical trial? Eligibility depends on factors like your specific cancer type, genetic profile of your tumor, prior treatments, and overall health. Genetic testing of your tumor for FGFR alterations is usually required. Speak to your oncologist about whether you may be a candidate for an erdafitinib trial.

Ongoing Clinical Trials on Erdafitinib

  • A study comparing erdafitinib delivery system to chemotherapy for patients with high-risk non-muscle-invasive bladder cancer who received BCG treatment

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Greece Italy The Netherlands +1

  • Study on the Effectiveness of Entrectinib and Other Drug Combinations for Patients with Advanced Solid Tumors, Multiple Myeloma, or Non-Hodgkin Lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study Comparing Erdafitinib and Mitomycin for Patients with Intermediate-risk Non-muscle Invasive Bladder Cancer with FGFR Gene Alterations

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +4

  • Study on Erdafitinib and Cetrelimab for Patients with Muscle-Invasive Bladder Cancer Ineligible for Cisplatin Treatment

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study on the Effectiveness and Safety of Erdafitinib, Midazolam, and Metformin in Patients with Advanced Urothelial Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

  • Study of erdafitinib treatment for adults and adolescents with advanced solid tumors having FGFR gene changes

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

  • Study on the Safety and Effectiveness of Erdafitinib Alone or with Cetrelimab and Chemotherapy for Patients with Metastatic or Advanced Urothelial Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study Comparing Erdafitinib with Vinflunine, Docetaxel, or Pembrolizumab for Patients with Advanced Urothelial Cancer and FGFR Gene Changes

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

  • Study of erdafitinib versus chemotherapy (gemcitabine or mitomycin) for patients with high-risk non-muscle-invasive bladder cancer with FGFR mutations who failed BCG therapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Poland

Glossary

  • Fibroblast Growth Factor Receptor (FGFR): A protein on cell surfaces that plays a role in cell growth, division, and formation of new blood vessels. Some cancers have changes in FGFR genes that can lead to increased cancer growth.
  • Tyrosine Kinase Inhibitor: A type of drug that blocks specific enzymes called tyrosine kinases, which are involved in many cell functions, including signaling, growth, and division. Erdafitinib is a tyrosine kinase inhibitor that targets FGFRs.
  • Genetic Alteration: A change in the DNA sequence of a gene. In cancer, certain genetic alterations can lead to uncontrolled cell growth. Erdafitinib targets cancers with specific FGFR genetic alterations.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. FGFR alterations are biomarkers that may indicate if a cancer could respond to erdafitinib.
  • Neoadjuvant Treatment: Treatment given before the main treatment, usually before surgery. Some trials are studying erdafitinib as neoadjuvant treatment for bladder cancer.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body. Clinical trials are evaluating the pharmacokinetics of erdafitinib in different patient populations.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment. This is a key measure of erdafitinib's effectiveness in clinical trials.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening. PFS is an important outcome measured in erdafitinib clinical trials.

References

  1. https://clinicaltrials.gov/study/NCT03066687
  2. https://clinicaltrials.gov/study/NCT04083976
  3. https://clinicaltrials.gov/study/NCT06328491
  4. https://clinicaltrials.gov/study/NCT03827850
  5. https://clinicaltrials.gov/study/NCT02699606
  6. https://clinicaltrials.gov/study/NCT06511648