INLYTA IS INDICATED FOR THE TREATMENT OF ADVANCED RCC AFTER FAILURE OF ONE PRIOR SYSTEMIC THERAPY. INLYTA—the ONLY approved treatment option to demonstrate superior PFS vs a TKI, sorafenib, in a phase 3 trial for 2nd-line mRCC* *Based on MEDLINE® literature review for phase 3 trials in mRCC as of February 2016. TKI=tyrosine kinase inhibitor. Primary endpoint: progression-free survival (PFS) 1.0 0.9 0.8 0.7 0.6 0.4 0.3 0.2 0.1 HR=0.67 (95% CI: 0.54, 0.81); P<.0001 For patients with moderate hepatic impairment, the starting dose should be decreased. INLYTA has not been studied in patients with severe hepatic impairment. Women of childbearing potential should be advised of potential hazard to the fetus and to avoid becoming pregnant while receiving INLYTA. Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose. Grapefruit or grapefruit juice may also increase INLYTA plasma concentrations and should be avoided. Avoid strong CYP3A4/5 inducers and, if possible, avoid moderate CYP3A4/5 inducers. The most common (≥20%) adverse events (AEs) occurring in patients receiving INLYTA (all grades, vs sorafenib) were diarrhea (55% vs 53%), hypertension (40% vs 29%), fatigue (39% vs 32%), decreased appetite (34% vs 29%), nausea (32% vs 22%), dysphonia (31% vs 14%), hand-foot syndrome (27% vs 51%), weight decreased (25% vs 21%), vomiting (24% vs 17%), asthenia (21% vs 14%), and constipation (20% vs 20%). The most common (≥10%) grade 3/4 AEs occurring in patients receiving INLYTA (vs sorafenib) were hypertension (16% vs 11%), diarrhea (11% vs 7%), and fatigue (11% vs 5%). The most common (≥20%) lab abnormalities occurring in patients receiving INLYTA (all grades, vs sorafenib) included increased creatinine (55% vs 41%), decreased bicarbonate (44% vs 43%), hypocalcemia (39% vs 59%), decreased hemoglobin (35% vs 52%), decreased lymphocytes (absolute) (33% vs 36%), increased ALP (30% vs 34%), hyperglycemia (28% vs 23%), increased lipase (27% vs 46%), increased amylase (25% vs 33%), increased ALT (22% vs 22%), and increased AST (20% vs 25%). Indication INLYTA is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. Please see Brief Summary on the following pages. All rights reserved. March 2016 Data are from a multicenter, open-label, phase 3 trial of 723 patients with mRCC after failure of 1st-line therapy (sunitinib-, temsirolimus-, bevacizumab-, or cytokinecontaining regimen 54%, 3%, 8%, and 35% of patients in each of the treatment arms, respectively). Patients were randomized 1:1 to either INLYTA 5 mg twice daily (n=361) or sorafenib 400 mg twice daily (n=362), with dose adjustments allowed in both groups. Primary endpoint was PFS. Secondary endpoints included objective response rate, overall survival, and safety and tolerability.1,2 Proportion progression-free 0.0 0 2 4 6 8 10 12 14 16 18 20 0.5 MONTHS (95% CI: 6.3, 8.6) (95% CI: 4.6, 5.6) with INLYTA (n=361) MONTHS with sorafenib (n=362) Time (months) Axitinib has a National Comprehensive Cancer Network® (NCCN®) category 1 recommendation as a subsequent therapy option, after either a TKI or a cytokine therapy in patients with advanced predominantly clear-cell RCC.3 INLYTA has been approved by the FDA for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
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