Beleodaq (belinostat) for injection is supplied as a sterile lyophilized yellow powder containing 500 mg belinostat as the active ingredient. Each vial also contains 1000 mg L-Arginine, USP as an inactive ingredient. The drug product is supplied in a single-dose 30 mL clear glass vial with a coated stopper and aluminum crimp seal with “flip-off” cap. Beleodaq is intended for intravenous administration after reconstitution with 9 mL Sterile Water for injection, and the reconstituted solution is further diluted with 250 mL of sterile % Sodium Chloride injection prior to infusion [see Dosage and Administration ( 2) ] .
The efficacy of TAGRISSO was demonstrated in two multicenter, single-arm, open-label clinical trials, AURA Extension and AURA2, in patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on prior systemic therapy, including an EGFR TKI. All patients were required to have EGFR T790M mutation-positive NSCLC as detected by the cobas ® EGFR mutation test and received TAGRISSO 80 mg once daily. The major efficacy outcome measure of both trials was ORR according to RECIST as evaluated by a Blinded Independent Central Review (BICR). Duration of response (DOR) and Progression-Free Survival (PFS) were additional outcome measures.