FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Altor BioScience Gains FDA Fast Track Designation for Bladder Cancer Drug

May 9, 2017
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Altor BioScience has received FDA fast track designation for its investigational interleukin-15 agonist complex, ALT-803, in combination with bacillus Calmette-Guérin (BCG), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC).

ALT-803 is currently being evaluated in a Phase Ib/II clinical trial of intravesical ALT-803 in combination with BCG in adult patients with BCG-naïve NMIBC as well as a separate Phase 2 clinical trial in combination with BCG in adult patients with BCG-unresponsive NMIBC.

The designation will apply to clinical development of ALT-803 in combination with BCG for the treatment and prophylaxis of carcinoma in situ of the urinary bladder, as well as for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection in patients with NMIBC.

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