BALVERSA (erdafitinib) Receives U.S. FDA Approval for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alterations
- BALVERSA is the first FGFR kinase inhibitor to receive U.S. FDA approval
- Simultaneous approval of companion diagnostic intended to identify a subset of patients most likely to benefit from BALVERSA, offering a personalized treatment approach
- susceptible FGFR3 or FGFR2 genetic alterations and
- progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
- Strong CYP2C9 or CYP3A4 inducers: Avoid concomitant use with BALVERSA. (7.1)
- Moderate CYP2C9 or CYP3A4 inducers: Increase BALVERSA dose up to 9 mg. (7.1)
- Serum phosphate level-altering agents: Avoid concomitant use with agents that can alter serum phosphate levels before the initial dose modification period. (2.3, 7.1)
- CYP3A4 substrates: Avoid concomitant use with sensitive CYP3A4 substrates with narrow therapeutic indices. (7.2)
- OCT2 substrates: Consider alternative agents or consider reducing the dose of OCT2 substrates based on tolerability. (7.2)
- P-gp substrates: Separate BALVERSA administration by at least 6 hours before or after administration of P-gp substrates with narrow therapeutic indices, (7.2)
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[1] BALVERSA Prescribing Information. [2] National Cancer Institute. NCI Dictionary of Cancer Terms. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/recist. Accessed April 2019. [3] American Cancer Society. ?What is Bladder Cancer.? Available at https://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html. Accessed April 2019. [4] National Cancer Institute. "Bladder Cancer Treatment (PDQ?)?Health Professional Version". Available at: https://www.cancer.gov/types/bladder/hp/bladder-treatment-pdq#link/_21_toc. Accessed April 2019. [5] Helsten et al. The FGFR Landscape in Cancer: Analysis of 4,853 Tumors by Next-Generation Sequencing. Clin Cancer Res. 2015;22(1):259-267. [6] Tomlinson et al. FGFR3 protein expression and its relationship to mutation status and prognostic variables in bladder cancer. J Pathol. 2007;213(1):91-98. [7] Dienstmann R, Rodon J, Prat A, et al. Genomic aberrations in the FGFR pathway: Opportunities for targeted therapies in solid tumors. Ann Oncol. 2014;25:552?563. [8] Janssen Pharmaceuticals, Inc. Data on file. [9] U.S. and World Population Clock. https://www.census.gov/popclock/. Accessed April 2019. [10] Bladder Cancer: Statistics. Available at: https://www.cancer.net/cancer-types/bladder-cancer/statistics. Accessed April 2019.- Media Inquiries: Michelle Larkin Phone: 1-610-304-5842 Brian Kenney Phone: 1-215-620-0111 Investor Relations: Christopher DelOrefice Phone: 1-732-524-2955 Lesley Fishman Phone: 1-732-524-3922 U.S. Medical Inquiries: 1-800-526-7736