$ImmunityBio (IBRX.US)$ Reminder – Yesterday's FDA news is r...
$ImmunityBio (IBRX.US)$ Reminder – Yesterday's FDA news is relevant. Here’s why.
Non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) unresponsive to BCG accounts for only about 10% of (BCG-unresponsive) disease, while the less aggressive papillary type makes up the remaining 90%.
Therefore, if the FDA approves ANKTIVA for papillary treatment, TAM demand will increase ninefold. We are still only talking about bladder cancer.
Now, ImmunityBio believes it has found a way forward through the latest developments. In fact, the company stated on Tuesday that the U.S. Food and Drug Administration (FDA) recommended the company provide "additional information" to support the resubmission of the sBLA.
ImmunityBio added that this "does not involve initiating or designing any new clinical trials." The company plans to submit the new information to the agency within the next 30 days.
The team highlighted the long-term outcomes of Quilt-3.032 recently published in The Journal of Urology. These showed that the 12-month DFS and PFS rates for Anktiva plus BCG were 58% and 95%, respectively, with 92% of patients avoiding cystectomy (bladder removal surgery) within one year.
ImmunityBio described these results as "unprecedented."
Non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) unresponsive to BCG accounts for only about 10% of (BCG-unresponsive) disease, while the less aggressive papillary type makes up the remaining 90%.
Therefore, if the FDA approves ANKTIVA for papillary treatment, TAM demand will increase ninefold. We are still only talking about bladder cancer.
Now, ImmunityBio believes it has found a way forward through the latest developments. In fact, the company stated on Tuesday that the U.S. Food and Drug Administration (FDA) recommended the company provide "additional information" to support the resubmission of the sBLA.
ImmunityBio added that this "does not involve initiating or designing any new clinical trials." The company plans to submit the new information to the agency within the next 30 days.
The team highlighted the long-term outcomes of Quilt-3.032 recently published in The Journal of Urology. These showed that the 12-month DFS and PFS rates for Anktiva plus BCG were 58% and 95%, respectively, with 92% of patients avoiding cystectomy (bladder removal surgery) within one year.
ImmunityBio described these results as "unprecedented."
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