b'Scan this QR code or visit LONSURFhcp.com to learn more about this combination regimenLONSURF + bevacizumab IMPROVED OVERALL SURVIVAL 1REDEFINE EXPECTATIONS EFFICACY: PRIMARY ENDPOINTMedian OS increased by 3.3 monthsIN 3L mCRC 10019080 10.8LONSURF in combination 70 months LONSURF + bevacizumab (n=246)Percentage of patients(9.4-11.8)60 LONSURF (n=246)with bevacizumab 50 HR=0.61 ([95% CI: 0.49-0.77]; P0.001)40INDICATION 30 7.5LONSURF is indicated as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic20 monthscolorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF10 (6.3-8.6)biological therapy, and if RAS wild-type, an anti-EGFR therapy.0SELECTED IMPORTANT SAFETY INFORMATION 0 1 23 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20WARNINGS AND PRECAUTIONS No. at risk MonthSevere Myelosuppression: In the 1114 patients who received LONSURF as a single agent, LONSURF caused severe orLONSURF + bevacizumab 246 244 239 230 217 203 183 160 149 131 119 104 88 69 52 37 24 13 2 0 0life-threatening myelosuppression (Grade 3-4) consisting of neutropenia (38%), anemia (17%), thrombocytopenia (4%) andLONSURF 246 242 230 205 184 163 143 120 108 95 85 76 63 44 24 16 10 5 2 1 0febrile neutropenia (3%). Three patients (0.3%) died due to neutropenic infection/sepsis; four other patients (0.5%) died dueResults were consistent across subgroups regardless of age, sex, location of primary disease, to septic shock. A total of 14% of patients received granulocyte-colony stimulating factors. In the 246 patients who receivednumber of metastatic sites, RAS mutation status, and prior bevacizumab treatment. 2LONSURF in combination with bevacizumab, LONSURF caused severe or life-threatening myelosuppression (Grade 3-4) consisting of neutropenia (52%), anemia (5%), thrombocytopenia (4%) and febrile neutropenia (0.4%). One patient (0.4%) died due to abdominal sepsis and two other patients (0.8%) died due to septic shock. A total of 29% of patients receivedSUNLIGHT Study Design 1granulocyte-colony stimulating factors. Obtain complete blood counts prior to and on Day 15 of each cycle of LONSURF andSUNLIGHT was a phase 3, international, randomized, open-label study to evaluate the efficacy and safety of LONSURF more frequently as clinically indicated. Withhold LONSURF for severe myelosuppression and resume at the next lower dosage.used in combination with bevacizumab vs LONSURF alone in patients with previously treated mCRC. The primary EmbryoFetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnantendpoint was OS and a secondary endpoint was PFS.women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the final dose.3L, third-line; mCRC, metastatic colorectal cancer; OS, overall survival; PFS, progression-free survival.USE IN SPECIFIC POPULATIONS SELECTED IMPORTANT SAFETY INFORMATION (contd) Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess theUSE IN SPECIFIC POPULATIONS (contd)effects of LONSURF or its metabolites on the breastfed child or the effects on milk production. Because of the potential forHepatic Impairment: Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin 1.5 times ULN serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LONSURF and for 1 dayand any AST) hepatic impairment. Patients with severe hepatic impairment (total bilirubin 3 times ULN and any AST) were not following the final dose.studied. No adjustment to the starting dosage of LONSURF is recommended for patients with mild hepatic impairment.Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potentialADVERSE REACTIONSto use condoms during treatment with LONSURF and for at least 3 months after the final dose.Serious adverse reactions occurred in 25% of patients. The most frequent serious adverse reactions (2%) were intestinal Geriatric Use: Patients 65 years of age or older who received LONSURF in combination with bevacizumab had a higherobstruction (2.8%), and COVID-19 (2%). Fatal adverse reactions occurred in 1.2% of patients who received LONSURF in incidence of the following hematologic laboratory abnormalities compared to patients younger than 65 years: Grade 3 or 4combination with bevacizumab, including rectal fistula (0.4%), bowel perforation (0.4%) and atrial fibrillation (0.4%). neutropenia (60% vs 46%) and Grade 3 or 4 thrombocytopenia (5% vs 4%). Renal Impairment: No adjustment to the starting dosage of LONSURF is recommended in patients with mild or moderate renal impairment (CLcr of 30 to 89 mL/min). Reduce the starting dose of LONSURF for patients with severe renal impairmentPlease see brief summary of Prescribing Information (CLcr of 15 to 29 mL/min) to a recommended dosage of 20 mg/m.on adjacent pages.2Taiho_Directory_USMed_Dec2023_FullAd_NAout_7.875x10.75_L09.indd 1 11/27/23 6:17 PM Taiho_Directory_USMed_Dec2023_FullAd_NAout_7.875x10.75_L09.indd 2 11/27/23 6:17 PM'