BALVERSA (erdafitinib) is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible FGFR3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Urothelial cancer, also known as urothelial carcinoma or transitional cell carcinoma, is a type of cancer that originates in the urothelial cells lining the urinary tract, including the bladder, ureters, and renal pelvis. It is the most common form of bladder cancer, representing over 90% of all cases. Risk factors for urothelial cancer include smoking, exposure to certain industrial chemicals, and chronic irritation of the bladder lining. Symptoms typically include hematuria (blood in the urine), frequent urination, and pelvic pain. Diagnosis is confirmed through urine cytology, cystoscopy, and imaging tests. Treatment options vary based on the stage and grade of the cancer and may include surgery, chemotherapy, radiation therapy, and immunotherapy. Early detection and intervention are crucial for improving patient outcomes.
Companion diagnostic testing plays a crucial role in the decision to prescribe BALVERSA (erdafitinib) by identifying patients with specific genetic alterations in their tumors. BALVERSA is approved for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations. A companion diagnostic test is used to detect these FGFR genetic alterations in the tumor, ensuring that only patients whose cancers harbor these specific mutations are considered for treatment. This personalized approach enhances the effectiveness of the therapy by targeting the cancer cells more precisely, improving patient outcomes while minimizing unnecessary exposure to the drug for those who would not benefit from it.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
BALVERSA (erdafitinib) is an oral kinase inhibitor used to treat adults with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations. It is specifically indicated for patients whose cancer has progressed during or following at least one line of prior platinum-containing chemotherapy.
BALVERSA targets and inhibits the activity of fibroblast growth factor receptors (FGFRs), which are involved in the growth and survival of cancer cells. By blocking these receptors, BALVERSA can help reduce tumor growth and spread in patients with FGFR-altered urothelial carcinoma.
BALVERSA is intended for adults with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations. Patients should have undergone at least one line of prior platinum-containing chemotherapy. Eligibility is determined through a companion diagnostic test that identifies the presence of specific FGFR genetic alterations.
A companion diagnostic test is a laboratory test used to detect specific genetic alterations in a patient’s tumor. For BALVERSA, this test identifies FGFR3 or FGFR2 genetic alterations, ensuring that only patients who are likely to benefit from the drug receive it. This personalized approach helps improve treatment efficacy and safety.
Common side effects of BALVERSA include increased phosphate levels, mouth sores (stomatitis), fatigue, increased creatinine levels, diarrhea, dry mouth, nail disorders, and changes in liver enzyme levels. Patients should discuss potential side effects with their healthcare provider and report any adverse reactions they experience during treatment.
Patients should consult with their oncologist or healthcare provider to determine if BALVERSA is an appropriate treatment option based on their genetic testing results. Healthcare providers can order the necessary companion diagnostic tests and guide patients through the process of accessing BALVERSA, including managing insurance coverage and support programs.
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenUS and @JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
