FDA col­lab­o­rates with Health Cana­da, Aus­tralia to ap­prove new can­cer drugs

The FDA on Tues­day un­veiled a new ini­tia­tive where­by its On­col­o­gy Cen­ter of Ex­cel­lence (OCE) will work to ap­prove new can­cer drugs along­side Aus­tralia’s Ther­a­peu­tic Goods Ad­min­is­tra­tion (TGA) and Health Cana­da.

The col­lab­o­ra­tion, dubbed Project Or­bis, was launched with the FDA’s de­ci­sion with TGA and Health Cana­da to grant ac­cel­er­at­ed ap­proval to Ei­sai’s Lenvi­ma (lenva­tinib) in com­bi­na­tion with Mer­ck’s Keytru­da (pem­brolizum­ab) for the treat­ment of pa­tients with ad­vanced en­dome­tri­al car­ci­no­ma that is not mi­crosatel­lite in­sta­bil­i­ty-high (MSI-H) or mis­match re­pair de­fi­cient (dMMR), and who have dis­ease pro­gres­sion fol­low­ing pri­or sys­temic ther­a­py but are not can­di­dates for cu­ra­tive surgery or ra­di­a­tion.

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