Partner in Progress: Johnson & Johnson

BCAN is proud to collaborate with Johnson & Johnson in our shared commitment to improving the lives of bladder cancer patients and their families—both now and in the future.

The following content is sponsored by Johnson & Johnson.

About Bladder Cancer

Great strides have been made in cancer treatment over the past few decades, yet the standard of care in certain kinds of bladder cancer hasn’t significantly changed in 40 years. Patients and their loved ones are ready to look beyond age-old treatments and embrace an evolving landscape.

Mike’s Story

Watch bladder cancer warrior Mike’s inspiring and uplifting story about how he and his wife, Heidi, and their sons have navigated his bladder cancer diagnosis and treatment journey, and how he became a fearless advocate for the bladder cancer community.

Frank’s Story

Podcast

An Innovative Treatment Giving New Hope to Bladder Cancer Patients

Introducing INLEXZO™

INLEXZO™ is designed for patients seeking bladder preservation and is the first and only intravesical drug releasing system (iDRS) to provide extended local delivery of a cancer medication into the bladder. INLEXZO™ remains in the bladder for three weeks per treatment cycle for up to 14 cycles.

A healthcare professional places INLEXZO™ into the bladder using a co-packaged urinary catheter and stylet to insert it into the bladder.¹ INLEXZO™ is placed in an outpatient setting in a few minutes, without the need for general anesthesia or further monitoring immediately post-insertion within the healthcare provider’s office.

The approval of INLEXZO™ is supported by data from the SunRISe-1 (NCT04640623) single-arm, open-label Phase 2b clinical study. Results show 82 percent of patients with BCG-unresponsive NMIBC treated with INLEXZO™ achieved a complete response (CR), meaning no signs of cancer were found after treatment (95 percent confidence interval [CI], 72, 90).¹ This high response rate demonstrated strong durability, and 51 percent of these patients maintained a complete response for at least one year.¹

These findings represent a meaningful step forward for patients and physicians seeking alternatives to surgery while maintaining bladder preservation.

Read more about INLEXZO™ in BCAN’s bladder cancer treatment options database.

INLEXZO™ INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION
INLEXZO™ (gemcitabine intravesical system) is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

INLEXZO™ is contraindicated in patients with:

• Perforation of the bladder.
• Prior hypersensitivity reactions to gemcitabine or any component of the product.

WARNINGS AND PRECAUTIONS

Risks in Patients with Perforated Bladder
INLEXZO™ may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised.

Evaluate the bladder before the intravesical administration of INLEXZO™ and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.

Risk of Metastatic Bladder Cancer with Delayed Cystectomy
Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.

Of the 83 evaluable patients with BCG-unresponsive CIS treated with INLEXZO™ in Cohort 2 of SunRISe-1, 7 patients (8%) progressed to muscle invasive (T2 or greater) bladder cancer. Three patients (3.5%) had progression determined at the time of cystectomy. The median time between determination of persistent or recurrent CIS or T1 and progression to muscle invasive disease was 94 days.

Magnetic Resonance Imaging (MRI) Safety
INLEXZO™ can only be safely scanned with MRI under certain conditions. Refer to section 5.3 of the USPI for details on conditions.

Embryo-Fetal Toxicity
Based on animal data and its mechanism of action, INLEXZO™ can cause fetal harm when administered to a pregnant woman if systemic exposure occurs. In animal reproduction studies, systemic administration of gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final removal of INLEXZO™. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after final removal of INLEXZO™.

ADVERSE REACTIONS
Serious adverse reactions occurred in 24% of patients receiving INLEXZO™. Serious adverse reactions that occurred in >2% of patients included urinary tract infection, hematuria, pneumonia, and urinary tract pain. Fatal adverse reactions occurred in 1.2% of patients who received INLEXZO™, including cognitive disorder.

The most common (>15%) adverse reactions, including laboratory abnormalities, were urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased AST, decreased sodium, bladder irritation, and increased ALT.

USE IN SPECIFIC POPULATIONS

Pregnancy
There are no available data on the use of INLEXZO™ in pregnant women to inform a drug-associated risk.

Please see Embryo-Fetal Toxicity for risk information related to pregnancy.

Lactation
Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 week after final removal of INLEXZO™.

Females and Males of Reproductive Potential
Pregnancy Testing – Verify pregnancy status in females of reproductive potential prior to initiating INLEXZO™.

Contraception – Please see Embryo-Fetal Toxicity for information regarding contraception.

Infertility (Males) – Based on animal studies, INLEXZO™ may impair fertility in males of reproductive potential. It is not known whether these effects on fertility are reversible.

Geriatric Use
Of the patients given INLEXZO™ monotherapy in Cohort 2 of SunRISe-1, 72% were 65 years of age or older and 34% were 75 years or older. There were insufficient numbers of patients <65 years of age to determine if these patients respond differently to patients 65 years of age and older.

Please read full Prescribing Information and Instructions for Use for INLEXZO™.

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