Deadline for FDA review of Anktiva (N-803) April 23When the media starts talking about
Anktiva plus BCG as a possible
"new standard of care" it's good to remember that
Ruvidar PDT offers equivalent (likely better) efficacy, does not require the use of the scarce
BCG supplies and the
Ruvidar results are based on only 2 treatments as opposed to
N-803's 18 treatments.
FDA decisions to watch in 2024 March 5, 2024 .................
4. ImmunityBio’s Anktiva
Indication: BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ
PDUFA date: April 23, 2024
Anktiva, a novel IL-15 superagonist complex, is being tested in combination with Bacillus Calmette-Gurin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without Ta or T1 disease. The drug’s development pathway highlights a significant advancement in bladder cancer treatment, potentially offering a new standard of care for this challenging condition.
................. As a reminder, here are the CR results of Anktiva vs. Ruvidar PDT:
| Endpoint | N-803 CIS Cohort | Optimized Ruvidar PDT |
| Complete Response at any time | 71% | 64% |
| Duration of Response | | |
| Duration = 3 months | 55% | 62% |
| Duration = 6 months | 56% | 60% |
| Duration = 12 months | 45% | 40% |
| Duration = 15 months | ? | 39% |
| Duration = 18 months | 33% | ? |
At 18 months Ruvidar should have a higher durable CR rate than N-803 as Ruvidar efficacy is unlikely to drop much between 15 and 18 months.
Treatment with Anktiva (N-803) is dependent on BCG (which is in short supply), and to attain these results, patients must endure 18 treatments. Once the treatments stop it remains to be seen how long the CR will endure. The CR rate drops12% between 12 and 18 months. Not coincidentally, the last treatment is at the end of 13 months. Here is the treatment description. "All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus N-803 weekly for 6 consecutive weeks (induction). Patients without disease progression at Months 3, 6, 9 and 12 are eligible for continued BCG + N-803 treatment (maintenance). The study duration is 24 months." Here is a list of the treatments: Induction Treatments
Study Day 1 (start of Week 1)
Study Day 8 (start of Week 2)
Study Day 15 (start of Week 3)
Study Day 22 (start of Week 4)
Study Day 29 (start of Week 5)
Study Day 36 (start of Week 6)
Maintenance Treatments
Month 4 (~Week 13-14*):
Month 4 (~Week 14-15):
Month 4 (~Week 15-16):
Month 7 (~Week 28)
Month 7 (~Week 29)
Month 7 (~Week 30)
Month 10 (~Week 41)
Month 10 (~Week 42)
Month 10 (~Week 43)
Month 13 (~Week 53)
Month 13 (~Week 54)
Month 13 (~Week 55)