Sabine D. Brookman-May, Senior Vice President and Therapeutic Area Head of Urologic Oncology at Aura Biosciences, shared a post on LinkedIn by Christopher Cutie, Vice President and Disease Area Leader at Johnson and Johnson Innovative Medicine, adding:
“Couldn’t be prouder of my former colleagues at Johnson and Johnson Innovative Medicine – Christopher Cutie, Kiran Patel, and the SunRISe Bladder team – on today’s FDA approval of INLEXZO (formerly TAR-200) for BCG-unresponsive HR-NMIBC with CIS (± papillary).
This milestone is grounded in SunRISe-1 and made possible by the courage of patients and the tireless work of investigators. I may not be at J and J anymore, but I’m thrilled to have been part of this story.”
Quoting Christopher Cutie‘s post:
“Treatment options for some types of Bladder Cancer haven’t seen meaningful change in decades…until now.
Today, I’m proud and humbled to share that Johnson and Johnson has received FDA approval for our treatment for patients with certain types of non-muscle-invasive bladder cancer (NMIBC).
As a practicing urologist, I’ve had countless conversations with patients facing a bladder cancer diagnosis. I saw their frustration. I shared it.
We knew we needed a better way, not just incremental change, but a bold reimagining of how we deliver therapy to the bladder.
It’s what pushed me to make the leap from clinical practice to the start-up world, to uncover a better way for patients. Together with academia and industry partners, we set out to develop a new drug delivery system designed to extend local delivery of a cancer drug directly into the bladder. Current bladder treatments can be limited, as medications stay in the bladder for less than an hour at a time and may not reach all areas, while systemic treatments often struggle to access the inner lining where most bladder tumors originate. Perseverance and resilience fueled our every step.
When Johnson and Johnson acquired TARIS Biomedical, we gained a partner equally committed to transforming bladder cancer care. By harnessing decades of experience, scale, and focus on innovation, Johnson and Johnson has propelled our vision forward in ways no other company could. We both broadened and accelerated our vision and brought it to life in a way that could truly reach patients.
This approval is more than just a professional milestone – it’s a reminder of why I made this shift in the first place. It’s proof that when you listen to patients, trust your clinical instincts, and keep pushing forward, progress happens.
And this is just the beginning. We’re building toward a future where bladder cancer treatment is more targeted, less invasive, and centered on preserving what matters most to patients.
To the teams, investigators, and especially the patients who made this possible – thank you for your trust, partnership, and belief in the power of science.
You can learn more about the approval and what it means for patients here.”
Read about “FDA Approves Johnson and Johnson’s INLEXZO, First Breakthrough Bladder Cancer Treatment in 40 Years.”
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