Theralase Technologies Inc. V.TLT

FDA Approval of N-803 + BCG Combo Treatment one Step Closer

[Eoganacht]

FDA accepts application for N-803 in NMIBC

The FDA has accepted for review a biologics license application (BLA) for N-803 (Anktiva) for use in combination with Bacillus Calmette-Gurin (BCG) for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without Ta or T1 disease, according to ImmunityBio, the developer of the IL-15 superagonist.1
 

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“This BLA acceptance brings us a very important step closer to being able to offer this promising combination therapeutic to more people living with NMIBC and, ultimately, reduce the incidence of cystectomies,” Patrick Soon-Shiong, MD, executive chairman and global chief scientific and medical officer at ImmunityBio, stated in a press release. “This is a compelling example of the power of inducing trained innate immune memory to potentially provide long-term, durable effects against serious, life-threatening diseases.”

[Rumpl3StiltSkin]

These guys really aren't our competition though, right? BGC is hard to find. And soo many treatents needed....

[Eoganacht]

i think they're our competition in the sense that they're aiming to treat the same patient population. But, like you say, we've got lots of advantages, such as the fact that we need only one or two treatments and the fact that they're reliant on BCG. We'll get a fair comparison of efficacy and response durability as our trial progresses.

[Eoganacht]

And once TLD1433 is approved there's nothing to stop Theralase from going the combined route for even greater efficacy and durabilty of response, as CancerSlayer and others have already commented.