Balversa
Pharmacotherapy, metastatic Susceptible FGFR3 or FGFR2 genetic alterations, Condition has progressed during or following at least one line of prior platinum- containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy Metastatic Urothelial Carcinoma
Treatment
0 Active Studies for Balversa
Treatment for
Pharmacotherapy
What is Balversa
Erdafitinib
The Generic name of this drug
Treatment Summary
In April 2019, the FDA approved Balversa (erdafitinib), a drug made by Janssen Pharmaceutical Companies. This is the first drug of its kind that targets fibroblast growth factor receptor (FGFR) genetic alterations in patients with advanced or metastatic urothelial carcinoma who have not responded to platinum-containing chemotherapy. The FDA also approved the therascreen FGFR RGQ RT-PCR Kit (Qiagen) as a companion diagnostic with Balversa, which helps to identify patients who may benefit from the treatment. Balversa is a breakthrough therapy for bladder cancer and is the
Balversa
is the brand name
Balversa Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Balversa
Erdafitinib
2019
3
Effectiveness
How Balversa Affects Patients
Erdafitinib is a drug that increases serum phosphate levels. To get the best results from the drug, it should be taken at the highest recommended dose so that the serum phosphate levels stay between 5.5-7.0 mg/dL. It's important to avoid taking any other drugs that also increase serum phosphate levels, or any medications with phosphate as an excipient, unless there are no other alternatives. In that case, phosphate binders may be used to manage phosphate elevation. Studies have also shown that erdafitinib has no major effect on the QTc interval.
How Balversa works in the body
Urothelial cancer is a type of cancer that begins in a thin layer of cells that lines the urinary system. It is usually bladder cancer, but can also occur in the upper urinary tract. Fibroblast growth factor receptor (FGFR) mutations and other changes are thought to be linked to the development of urothelial cancer. Erdafitinib is a drug that works by blocking the activity of FGFRs. It has been shown to inhibit FGFRs and reduce the growth of cells with FGFR mutations, in cell lines as well as in laboratory animal models with bladder cancer.
When to interrupt dosage
The advised dosage of Balversa is contingent upon the specified condition. The measure of dosage can be seen in the provided table, contingent upon the mode of delivery (e.g. Oral or Tablet).
Condition
Dosage
Administration
Pharmacotherapy
, 4.0 mg, 3.0 mg, 5.0 mg
Tablet, film coated - Oral, Tablet, film coated, , Oral, Tablet, Tablet - Oral
metastatic Susceptible FGFR3 or FGFR2 genetic alterations, Condition has progressed during or following at least one line of prior platinum- containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy Metastatic Urothelial Carcinoma
, 4.0 mg, 3.0 mg, 5.0 mg
Tablet, film coated - Oral, Tablet, film coated, , Oral, Tablet, Tablet - Oral
Warnings
There are 20 known major drug interactions with Balversa.
Common Balversa Drug Interactions
Drug Name
Risk Level
Description
Cisplatin
Major
The serum concentration of Cisplatin can be increased when it is combined with Erdafitinib.
Clofarabine
Major
The serum concentration of Clofarabine can be increased when it is combined with Erdafitinib.
Dalfampridine
Major
The serum concentration of Dalfampridine can be increased when it is combined with Erdafitinib.
Dofetilide
Major
The serum concentration of Dofetilide can be increased when it is combined with Erdafitinib.
Gentamicin
Major
The serum concentration of Gentamicin can be increased when it is combined with Erdafitinib.
Balversa Toxicity & Overdose Risk
Erdafitinib may cause harm to an unborn baby and should not be taken by pregnant women. Women and their male partners should also use contraception during treatment and for one month after the last dose. It is not recommended for use in pediatric patients. Those with a CYP2C9*3/*3 genotype should be monitored for increased side effects. Data is not available on the presence of erdafitinib in human milk or its effects on breastfed babies, so lactating women should not use this drug. Animal studies have not shown any mutagenic or carcinogenic effects, but it has been linked to
Balversa Novel Uses: Which Conditions Have a Clinical Trial Featuring Balversa?
There are currently no active trials exploring the potential of Balversa as a Pharmacotherapy agent.
Condition
Clinical Trials
Trial Phases
metastatic Susceptible FGFR3 or FGFR2 genetic alterations, Condition has progressed during or following at least one line of prior platinum- containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy Metastatic Urothelial Carcinoma
0 Actively Recruiting
Pharmacotherapy
0 Actively Recruiting
Patient Q&A Section about balversa
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What type of drug is BALVERSA?
"BALVERSA is a drug that prevents the kinase enzymes from working. By inhibiting these enzymes, BALVERSA can help to treat some types of cancer."
Answered by AI
Is BALVERSA chemotherapy?
"This medicine works by preventing the grown of cancer cells by blocking the FGFR protein.
Erdafitinib is a cancer medication used to treat patients with fibroblast growth factor receptor (FGFR) mutations. It is used for cancer that has progressed during or within 12 months of platinum-containing chemotherapy. This medicine works by blocking the FGFR protein to prevent the growth of cancer cells."
Answered by AI
How effective is BALVERSA?
"The study found that out of 87 bladder cancer patients who had undergone at least one prior chemotherapy treatment, Balversa elicited an overall response rate of 32.2%, including 2.3% complete responses, and it was able to stall tumor progression or death by a median of 5.4 months."
Answered by AI
What is BALVERSA used for?
"BALVERSA is a prescription medication used to treat adults with bladder cancer that has spread or cannot be removed through surgery. It is designed for those with a certain type of abnormal fibroblast growth factor receptor (FGFR) gene."
Answered by AI