2:00 PM
Apr 12, 2019
 |  BC Extra  |  Company News

J&J's Balversa gets accelerated approval for bladder cancer

Editor's Note: This article was updated on Apr 12, 2019 at 3:50 PM PDT

FDA granted Janssen's Balversa erdafitinib accelerated approval to treat bladder cancer, making it the first FGFR kinase inhibitor to gain U.S. approval.

Balversa is indicated to treat adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 alterations and who have progressed during or following at least one line of platinum-containing chemotherapy. FDA simultaneously approved the therascreen FGFR RGQ RT-PCR Kit from Qiagen N.V. (Xetra:QIA; NYSE:QGEN) for use as a companion diagnostic with Balversa.

Janssen spokesperson Brian Kenney told BioCentury Balversa will be available within the next week at a wholesale acquisition cost (WAC) ranging from $10,080 to $22,680 for a 28-day supply. Kenney said the cost of treatment will vary by patient depending on dose, and that the average cost per patient for a 28-day supply is $18,400.

The Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) said FDA based Balversa's approval on data from the Phase II BLC2001 trial in which the drug led to an objective response rate (ORR) of 32.2% among 87 evaluable patients with locally advanced or metastatic bladder cancer with FGFR3 or FGFR2 genetic alterations. Balversa has breakthrough therapy status in the U.S.

The approval triggered an undisclosed milestone payment to Astex Pharmaceuticals Inc., which discovered Balversa under a 2008 collaboration with Janssen. Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) acquired Astex in 2013.

Targets: FGFR - Fibroblast growth factor receptor; FGFR2 (KGFR; CD332) - Fibroblast growth factor receptor 2; FGFR3 (CD333) - Fibroblast growth factor receptor 3

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