ASH Clinical News Hematology Pipeline Update | Page 24

BECAUSE YOU CAN’T DO THIS TO FL… THERE’S ZYDELIG® A first-in-class selective inhibitor of PI3Kδ, a protein that is expressed in normal and malignant B cells ZYDELIG is a PI3Kδ inhibitor indicated for Relapsed FL after ≥2 systemic therapies The FL indication was granted accelerated approval based on ORR; improvement in patient survival or disease-related symptoms has not been established. FL=follicular B-cell non-Hodgkin lymphoma; ORR=overall response rate; PI3Kδ=phosphatidylinositol 3-kinase delta. IMPORTANT SAFETY INFORMATION BOXED WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, AND INTESTINAL PERFORATION • Fatal and/or serious hepatotoxicity occurred in 14% of ZYDELIG-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue ZYDELIG as recommended • Fatal and/or serious and severe diarrhea or colitis occurred in 14% of ZYDELIG-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue ZYDELIG as recommended • Fatal and serious pneumonitis can occur. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue ZYDELIG as recommended • Fatal and serious intestinal perforation can occur in ZYDELIG-treated patients. Discontinue ZYDELIG for intestinal perforation FL Please see the following pages for additional Important Safety Information and Brief Summary of full Prescribing Information, including BOXED WARNING. IMAGINE WHAT’S POSSIBLE