NOGAPENDEKIN ALFA INBAKIC-PMLN INJ,SOLN
Clinical Criteria Summary
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Exclusion Criteria
- Current or previous evidence of muscle-invasive or metastatic bladder cancer
- Pregnancy
- Lactating
Inclusion Criteria (All must be met)
- Formulary agents for BCG-unresponsive disease have been used previously unless there is a contraindication or they are not medically advisable
- In combination with Bacillus Calmette-Guerin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer
- Carcinoma in situ (CIS) with or without papillary tumors (Ta or T1 high-grade tumors)
Additional Clinical Requirements
- Care is provided by a VA/VA Community Care oncology or urology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- For females who can become pregnant and males with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 1 week after stopping treatment
Definition/Justification
- BCG-unresponsive: Received 2 courses of BCG within 12 months (5 of 6 induction instillations and at least 2 of 3 maintenance doses OR at least 2 of 6 instillations of a second induction when maintenance not given)
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Indication & Patient Population
- BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors
- Used specifically under use with BCG
- Trial population included patients with CIS ± Ta/T1 disease and Ta/T1 disease with complete resection
- Median age 71 years; 74-87% male; median prior BCG doses of 12
Dosage & Administration
- Dosage form: Solution for intravesical use
- Induction: 400mcg intravesically with BCG weekly for 6 weeks (may require 2nd induction)
- Maintenance: 400mcg intravescially with BCG once a week for 3 weeks at months 4, 7, 10, 13, and 19
- If complete response at week 25 or later, may continue maintenance with BCG weekly for 3 weeks months 25, 31, and 37
Safety & Monitoring Requirements
- Boxed warnings: None
- Contraindications: None
- Other warnings: Risk of lethal metastatic disease by delaying cystectomy
- Top 5 adverse events: Dysuria, hematuria, urinary frequency, urination urgency, urinary track infection
- Drug interactions: None
Clinical Context & Utilization Considerations
- Indicated for use with BCG in patients with BCG-unresponsive NMIBC
- Demonstrates clinical responses with less toxicity than systemic treatments and can be administered in the outpatient setting
- Ongoing BCG shortage may interfere with use as a therapeutic choice
- Alternative options include cystectomy, intravesical chemotherapy, pembrolizumab, nadofaragene firadenovec, or sequential gemcitabine and docetaxel