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Zydelig (Idelalisib) & Concomitant Use

    Basic Details
    Last Updated
    Thursday, September 19, 2019
    Health Outcome(s)
    concomitant use
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    Because the use of Zydelig in certain treatment regimens led to unacceptable levels of toxicity (pneumonitis, hepatitis, colitis), FDA evaluated the use of Zydelig concomitantly with other antineoplastic agents, in association with the labeled indication as well as other indications. The Sentinel analysis showed low observed rates of Zydelig concomitantly used with therapies which the labeled prescribing information describes as not indicated or not recommended. Based upon these data and analyses from other sources, FDA decided that no regulatory action was needed at this time.