The US FDA has granted approval for Johnson & Johnson’s drug delivery system aimed at treating bladder cancer, presenting a potential option for those who want to avoid surgery.
Known as Inlexzo, this system is intended for patients with non-muscle invasive bladder cancer who haven’t had success with Bacillus Calmette-Guerin (BCG) therapy, which is the current standard treatment.
Bamil Divan, an analyst with Guggenheim, commented, “Inlexzo could be a groundbreaking treatment that meets significant needs for patients with few alternatives after BCG therapy.”
Divan projects that Inlexzo could generate around $3.4 billion in revenue by 2040, highlighting its potential impact.
This approval is supported by findings from a mid-stage clinical trial in which over 82% of participants receiving Inlexzo showed no cancer signs, and more than half remained cancer-free for at least a year.
Christopher Cutie, J&J’s vice president and leader in the bladder cancer sector, mentioned that “the drug effectively puts the disease into remission at low doses over extended periods and appears to maintain its effects through immune memory,” prior to the FDA’s decision.
Inlexzo is administered directly into the bladder and is effective for three weeks throughout potentially up to 14 treatment cycles, according to the company.
The drug is designed to minimally impact daily life while continuously releasing the chemotherapy agent gemcitabine into the bladder.
Reported side effects typically include urinary frequency, urinary tract infections, and pain, as stated by J&J.
J&J acquired this drug back in 2019 through its purchase of Taris Biomedical, a private biotech firm.
This drug also has been trialed for patients dealing with muscle-invasive bladder cancer.
