FDA’s Project Or­bis may ex­pand to Sin­ga­pore and Switzer­land

The FDA may ex­pand a pi­lot project that al­lows for si­mul­ta­ne­ous drug ap­proval de­ci­sions from US, Cana­di­an and Aus­tralian reg­u­la­tors to in­clude Sin­ga­pore and Switzer­land, Richard Paz­dur, di­rec­tor of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence, said Tues­day at the Friends of Can­cer Re­search’s an­nu­al meet­ing in Wash­ing­ton, DC.

If Sin­ga­pore and Switzer­land are added, Paz­dur said fol­low­ing vis­its to both coun­tries, it would fur­ther col­lab­o­ra­tions be­tween the reg­u­la­tors as there’s cur­rent­ly a work-shar­ing agree­ment known as the Aus­tralia-Cana­da-Sin­ga­pore-Switzer­land (AC­SS) Con­sor­tium. Aus­tralia and Cana­da al­so pre­vi­ous­ly worked to­geth­er to ap­prove two can­cer drugs — Eli Lil­ly’s Verzenio (abe­maci­clib) in April for the treat­ment of metasta­t­ic breast can­cer and the Ju­ly 2018 ap­proval for Janssen’s prostate can­cer treat­ment apa­lu­tamide.

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