Product Code Database
Erdafitinib, sold under the brand name Balversa, is an anti-cancer medication. It is a small molecule inhibitor of fibroblast growth factor receptor (FGFR) used for the treatment of cancer. FGFRs are a subset of tyrosine kinases which are unregulated in some tumors and influence tumor cell differentiation, proliferation, angiogenesis, and cell survival. Astex Pharmaceuticals drug discovery the drug and licensed it to Janssen Pharmaceuticals for further drug development.
In April 2019, erdafitinib was granted approval by the US Food and Drug Administration (FDA) for treatment of metastatic or locally advanced bladder cancer with an FGFR3 or FGFR2 alteration that has progressed beyond traditional platinum-based therapies, subject to a confirmatory trial. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.
In January 2024, the FDA approved erdafitinib for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy.
In August 2024, the EMA approved erdafitinib for adults with unresectable or metastatic urothelial carcinoma (mUC) carrying susceptible FGFR3 genetic alterations.
Erdafitinib may cause serious eye problems, including inflamed eyes, inflamed cornea (front part of the eye) and disorders of the retina, an internal part of the eye. Patients are advised to have eye examinations intermittently and to tell their health care professional right away if they develop blurred vision, loss of vision or other visual changes.
Erdafitinib received an accelerated approval. Further clinical trials are required to confirm erdafitinib's clinical benefit and the sponsor is conducting or plans to conduct these studies. Erdafitinib was also granted breakthrough therapy designation. The FDA granted the approval of Balversa to Janssen Pharmaceutical. The FDA also approved the therascreen FGFR RGQ RT-PCR Kit, developed by Qiagen Manchester, Ltd., for use as a companion diagnostic with erdafinitib for this therapeutic indication.
In January 2024, the FDA approved erdafitinib for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. This approval amends the indication previously granted under accelerated approval for people with metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy. Efficacy was evaluated in Study BLC3001 Cohort 1, a randomized, open-label trial of 266 participants with metastatic urothelial carcinoma harboring selected FGFR3 alterations who had received 1-2 prior systemic treatments, including a PD-1 or PD-L1 inhibitor. Participants were randomized 1:1 to receive erdafitinib or investigator's choice of chemotherapy (docetaxel or vinflunine). Randomization was stratified by region, performance status, and presence of visceral or bone metastases. FGFR3 alterations were identified from tumor tissue in a central laboratory by the therascreen FGFR RGQ RT-PCR kit (Qiagen) in 75% of participants, while the remainder were identified by local next generation sequencing assays.
In June 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Balversa, intended for the treatment of urothelial carcinoma harbouring susceptible FGFR3 genetic alterations. The applicant for this medicinal product is Janssen-Cilag International N.V. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Erdafitinib was approved for medical use in the European Union in August 2024.
|
|
