Janssen's Balversa gets FDA nod

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Janssen's Balversa gets FDA nod

By Sandra Levy - 04/15/2019
Janssen Pharmaceutical has received the Food and Drug Administration's blessing for Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.

Janssen is offering Balversa and associated patient services through a single-source specialty pharmacy provider, US Bioservices.

"We recognize the significant unmet need that persists in the treatment of men and women diagnosed with this form of urothelial carcinoma, and we have worked expeditiously to develop Balversa for patients in close consultation with the FDA," Janssen research and development evelopment global therapeutic area head, oncology, Peter Lebowitz said. "We look forward to the continued development of Balversa to understand how this important new therapy may further inform the care of patients with metastatic urothelial carcinoma and its investigational use in other cancers where FGFR alterations may be present in the future."

"The FDA approval of Balversa represents our commitment to deliver much-needed therapies for devastating diseases, including metastatic urothelial carcinoma where there is a lack of therapeutic options," Mathai Mammen, Janssen Research & Development global head said. "We are also pleased to see the simultaneous FDA approval of a companion diagnostic with Balversa, which will offer a more personalized approach to therapy for healthcare professionals to treat their patients."

"We're in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient's specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types. Today's approval represents the first personalized treatment targeting susceptible FGFR genetic alternations for patients with metastatic bladder cancer," said Richard Pazdur, director of the FDA's oncology center of excellence, and acting director of hematology and oncology products in the FDA's Center for Drug Evaluation and Research.