On April 12, 2019, Johnson and Johnson received FDA approval for Balsera (erdafitnib), a drug meant to treat advance metastatic urothelial carcinoma. A disease that progresses after chemotherapy for patients suffering from a genetic mutation in FGFR2 and FGFR3 gene. Urolthelial carcinoma is a form of cancer that starts in the innermost lining of the bladder is the most common form of bladder cancer, affecting 90 percent of patients.
A victory for Johnson and Johnson, not until Balversa’s approval did patients suffering from advanced metastatic bladder cancer had a treatment for their disease. Balversa is the first FGFR kinase inhibitor to be approved by the FDA. The approval by the FDA comes from its breakthrough designation in March 2018 and priority designation in September 2018, the FDA fast track their approval after Phase 2 clinical trials showed a response rate of 32.2% in Objective Response Rate (ORR) ( BLC2001, NCT02365597).
In order for patients to get Balversa, patients will need to find out whether they have a FGFR mutation. The diagnostic test that will be accompany this drug is QIAGEN therascreen® FGFR RGQ Reverse-transcription (RT)-polymerase chain reaction (PCR) test, the only test that detects FGFR muations.
Alex Gorsky from the company managed to dub the drug as a potential blockbuster. Getting J&J’s Balversa for a 28 day supply of Balversa will cost anywhere from $10,000 to $22,000. Depending on the dosage, with higher dosages commending a higher price for the drug. An average cost of $18,400 is something more reasonable to charge patients since that is the price that other oral oncology medications are going.
Getting the FDA approval is huge for J&J’s Balversa and the interesting thing is that it got the approval quite fast after its phase 2 clinical study. With a response rate of 32.2% it managed to stall the tumor progression or death by around 5.4 months on average. A drug treating and improving the quality of life of their patients.
J&J’s Balversa is another addition to their drug pipeline, they have continue to get drug approvals and the last drug that was approved was Erleada. A drug meant to treat prostate cancer.
“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 alterations for patients with metastatic bladder cancer,”
-Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research
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