Janssen has snagged the FDA’s breakthrough status on its solid tumor drug candidate erdafitinib, putting J&J one step closer to its lofty goal of bringing numerous new blockbuster drugs to market.
The drug, an FGFR inhibitor, got the designation for its potential to treat patients with metastatic urothelial cancer. Urothelial cancer is the sixth most common type of cancer in the US, most frequently showing up in the bladder.
“For patients diagnosed with urothelial cancer, outcomes are unfortunately disheartening due to the aggressiveness of the disease,” said Peter Lebowitz, Janssen’s global oncology head, in a statement. “Through the continued development of erdafitinib, and working closely with the FDA, we look forward to bringing a potential new treatment option to patients.”
The breakthrough therapy designation is based on data from a Phase II trial. The data, presented at ASCO, show an overall response rate of 42% in 59 patients with relapsed/refractory metastatic urothelial cancer whose tumors harbored actionable FGFR mutations.
Erdafitinib is one of 11 blockbuster hopefuls in J&J’s pipeline — a list the pharma giant touted last summer, each with a peak sales promise of $1 billion-plus. The top drugs include two new immunology drugs already filed for approval and well known to investors: guselkumab for psoriasis and sirukumab for rheumatoid arthritis. The remaining therapies cover a range of focuses, but with a notable concentration in oncology.
J&J needs them all to keep up with an ambitious growth forecast for its pharma division revenue.
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