8. Balversa

(Johnson & Johnson)

Active ingredient: erdafitinib
Disease: bladder cancer
Peak sales estimate: over $1 billion
Approved: April 12, 2019
Company: Johnson & Johnson

The scoop: Johnson & Johnson’s Balversa is the first targeted therapy approved by the FDA to treat bladder cancer. It’s now allowed in previously chemo-treated patients whose tumors have an FGFR3 or FGFR2 mutation. In a small phase 2 trial that led to the accelerated approval, Balversa triggered an overall response rate of 32.2%, stalling tumor progression or death by a median of 5.4 months. To confirm its benefit, J&J is conducting a confirmatory trial dubbed Thor that pits the FGFR inhibitor against chemo and Merck & Co.’s PD-1 inhibitor Keytruda. J&J has high hopes for the drug, highlighting it and antidepressant Spravato as two new launches with blockbuster potential. J&J’s entire oncology portfolio could use some sales boost. That portfolio’s bestselling drug, prostate cancer therapy Zytiga, dropped amid copycat competition. And Erleada is now fighting both Pfizer and Astellas’ Xtandi and Bayer’s newly approved Nubeqa. — Angus Liu

8. Balversa

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