The Janssen Pharmaceutical Companies of Johnson & Johnson announced that BALVERSA™ (erdafitinib) received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 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.1 BALVERSA is the first FGFR kinase inhibitor approved by the FDA. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1 Today’s approval follows FDA Breakthrough Therapy Designation in March 2018 and Priority Review Designation of the New Drug Application submitted in September 2018.
Janssen is offering BALVERSA and associated patient services through a single source specialty pharmacy provider, US Bioservices. This model is part of Janssen’s ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.
Mathai Mammen, Global Head of R&D for the Janssen Pharmaceutical Companies of Johnson & Johnson shared on Linkedin, ‘‘I am very proud of the Janssen team that worked for many years and overcame many significant challenges to bring forward Balversa (erdafitinib) from our labs to patients with bladder cancer that possess a particular molecular signature. It is extraordinarily difficult to progress first-in-class therapies, as there will always be questions, risks, doubts. Success requires a team with passion, creativity and grit, and of course incredible talent and conviction born of data. This drug will save lives’’.