Tis­sue-ag­nos­tic drug de­vel­op­ment: FDA on­col­o­gy cen­ter of­fers draft guid­ance

With the rise of Mer­ck’s Keytru­da and Bay­er’s Vi­t­rakvi, which have won ac­cel­er­at­ed ap­provals over the last five years for ge­net­i­cal­ly-tar­get­ed (rather than tis­sue-tar­get­ed) can­cer ther­a­pies, the FDA on Mon­day re­leased new draft guid­ance to help can­cer drug de­vel­op­ers try to make sim­i­lar strides.

Back in May 2017, the FDA signed off on an ac­cel­er­at­ed ap­proval for the block­buster Keytru­da for adult and pe­di­atric pa­tients with un­re­sectable or metasta­t­ic, mi­crosatel­lite in­sta­bil­i­ty-high (MSI-H) or mis­match re­pair de­fi­cient (dMMR) sol­id tu­mors that have pro­gressed fol­low­ing pri­or treat­ment. As the first tis­sue/site-ag­nos­tic ap­proval, the agency not­ed at the time that the tri­al on which the ap­proval was based in­clud­ed pa­tients with col­orec­tal can­cer and 14 oth­er can­cer types.

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