IDHIFA

批准信原文要点

This Prior Approval sNDA provides for updates to the United States Prescribing Information (USPI) in Section 12.3 Pharmacokinetics based upon data from Study CC--90007-CP-007.

批准信原文要点

This new drug application provides for the use of Idhifa® (enasidenib) tablets, 50 and 100 mg, for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

批准信原文要点

This Prior Approval sNDA provides for the following based upon the results of study CC-90007-CP-004 designed to fulfil PMR 3240-4: • Revisions to Section 5 Warnings and Precautions, subsection 5.2 Embryo-Fetal Toxicity; Section 8 Use In Specific Populations, subsections 8.1 Pregnancy; 8.2 Lactation, 8.3 Females and Males of Reproductive Potential, and Section 17 Patient Counseling Information to align with current labeling practices; • Revisions to Section 7 Drug Interactions; subsection 7.1 Effect of IDHIFA on Other Drugs and Section 12.3 Clinical Pharmacology to reflect effect of enasidenib on the single dose pharmacokinetics of sensitive substrates of CYP1A2, CYP3A4, CYP2D6, CYP2C19, CYP2C9, CYP2C8, P-gp, OATP1B1, OATP1B3 and BCRP to address the potential for excessive drug toxicity;

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for changes to the concentration of the sensitivity solution used in the HPLC-MS method for the drug substance.

批准信原文要点

This Prior Approval supplemental new drug application provides for the following: • Revisions to Sections 7.1 Effect of IDHIFA on Other Drugs and 12.3 Pharmacokinetics of the United States Prescribing Information (USPI) to include specific information on substrates and transporter systems; • Revisions to Section 17 Patient Counseling Information of the USPI to include the Drug Interactions subsection; • Minor editorial edits in Sections 5.2 Embryo-Fetal Toxicity, 8.1 Pregnancy, 8.2 Lactation, 8.3 Females and Males of Reproductive Potential and 17 Patient Counseling Information of the USPI; • Revisions to the Medication Guide to reflect changes in Section 17 of the USPI.

批准信原文要点

This Prior Approval supplemental new drug application provides for the following revisions to the United States Prescribing Information: Updated elimination half-life and Cmax concentrations (Section 12.3), Updated timeframe for contraceptive use following discontinuation of IDHIFA (Sections 5.2, 8.3, and 17, and Medication Guide), and Updated timeframe in which differentiation syndrome has been observed (Section 5.1).