FDA of­fers new draft guid­ance on can­cer drug dose op­ti­miza­tion with over­haul of max­i­mum tol­er­at­ed dose par­a­digm

Al­though spon­sors of can­cer drugs have his­tor­i­cal­ly gone af­ter the max­i­mum tol­er­at­ed dose (MTD), par­tic­u­lar­ly with chemother­a­py, the FDA re­leased new draft guid­ance to­day ex­plain­ing how that tra­di­tion­al par­a­digm needs to be tweaked with more tar­get­ed can­cer drugs.

The re­forms are nec­es­sary as the FDA notes that this cur­rent par­a­digm can re­sult in a rec­om­mend­ed dosage that is poor­ly tol­er­at­ed, ad­verse­ly im­pacts qual­i­ty of life, and may hurt a pa­tient’s abil­i­ty to re­main on a drug.

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