The FDA has approved Johnson & Johnson‘s (JNJ) INLEXZO™ (gemcitabine intravesical system), a new localized medication delivery system that has the potential to revolutionize the way patients with a difficult type of non-muscle invasive bladder cancer (NMIBC) are treated. For adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS), a high-risk malignancy limited to the inner lining of the bladder, the approval, which was given to Johnson & Johnson, provides a substantial new bladder-sparing option.
With this historic ruling, the first and only intravesical drug-releasing system (iDRS) that delivers the chemotherapeutic gemcitabine locally and continuously into the bladder is introduced. With its high rates of full response and long-lasting effectiveness, INLEXZOTM is a significant improvement for a patient population that frequently faces the potentially life-altering prospect of radical cystectomy (total bladder removal surgery).
When we acquired this novel therapy in 2019, our ambition was to give patients with bladder cancer a renewed sense of hope and belief,
In an area that has seen little progress for more than 40 years, INLEXZO delivers a first-of-its-kind breakthrough innovation with a bright future ahead.
Jennifer Taubert
The approval is predicated on the very favorable outcomes of the Phase 2b, single-arm SunRISe-1 research. According to the experiment, a remarkable 82% of patients treated with INLEXZOTM experienced a full response, which means that there were no observable symptoms of bladder cancer. Additionally, 51% of these patients were still in full response at the one-year point, demonstrating the durability of the response.
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About 75% of bladder cancer cases are NMIBC, making it the most prevalent kind. Transurethral resection of the bladder tumor (TURBT) followed by intravesical BCG immunotherapy is the standard of care for high-risk NMIBC. A considerable percentage of patients, however, either do not respond to BCG or suffer from disease recurrence, which leaves them with a dismal prognosis and the difficult decision of bladder resection.
Formerly known as TAR-200, INLEXZO™ was created to fill this important gap. In a straightforward in-office surgery, a urologist inserts this tiny, flexible device-like system into the bladder without the need for general anesthesia. Over the course of a three-week therapy cycle, the system stays in the bladder and releases gemcitabine constantly.
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In the SunRISe-1 study, INLEXZOTM’s safety profile was determined to be controllable. Urinary frequency, urinary tract infection, painful urination (dysuria), and blood in the urine (hematuria) were the most frequently reported side effects.
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About INLEXZO™ (gemcitabine intravesical system)
Adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, can be treated with INLEXZOTM, an intravesical drug-releasing device. It is intended to administer gemcitabine locally and continuously to the bladder lining. In a medical professional’s office, the device is placed into the bladder using a urinary catheter.
Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
