COMPANION DIAGNOSTICS Companion Diagnostic Assay Successfully Developed for Use in Phase III Trial BY CHRISTINA BENNETT, MS R esearchers reported the suc-cessful development of a companion diagnostic as-say that can identify which patients with advanced triple-negative breast cancer (TNBC) could respond to enzalutamide, currently approved for metastatic castration-resistant prostate cancer ( Abstract P6-07-01 ). The results of the study were reported in a poster session at the 2016 San Antonio Breast Cancer Symposium. Currently, there are no targeted ther-apies approved for TNBC, the heteroge-neity of which now recognized, so the Continued on page 11 Make IBRANCE® (palbociclib) a part of your standard of care Experience with IBRANCE continues to grow nationwide 21+ months since initial FDA approval 8,900+ oncologists prescribing IBRANCE 5 44,000+ patients prescribed IBRANCE 5 Access for patients is a priority • Low co-pay: Pﬁ zer’s Co-Pay One Savings Program off ers a $10 monthly maximum out-of-pocket IBRANCE cost for eligible, commercially insured patients* • Support for your underinsured or uninsured patients: Pﬁ zer RxPathways® connects patients with services that may help them get started on IBRANCE * Limits, terms, and conditions apply. This off er is only available at participating pharmacies. This off er is not health insurance. No membership fees. Please see the full terms and conditions at www.Pﬁ zerCoPayOne.com/Pharmacist. For help in answering pharmacy process questions, call 1-855-612-1951 . Pﬁ zer Inc, 235 East 42nd Street, New York, NY 10017. Visit IBRANCEhcp.com to learn more Important Safety Information (cont.) Grade 3/4 adverse reactions ( ű 10%) in PALOMA-1 reported at a higher incidence in the IBRANCE plus letrozole group vs the letrozole alone group included neutropenia (54% vs 1%) and leukopenia (19% vs 0%). The most frequently reported serious adverse events in patients receiving IBRANCE plus letrozole were pulmonary embolism (4%) and diarrhea (2%). Lab abnormalities occurring in PALOMA-1 (all grades, IBRANCE plus letrozole vs letrozole alone) were decreased WBC (95% vs 26%), decreased neutrophils (94% vs 17%), decreased lymphocytes (81% vs 35%), decreased hemoglobin (83% vs 40%), and decreased platelets (61% vs 16%). Avoid concurrent use of strong CYP3A inhibitors . If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg/day. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers . The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure. IBRANCE has not been studied in patients with moderate to severe hepatic impairment or in patients with severe renal impairment (CrCl <30 mL/min). Please see Important Safety Information throughout, followed by Brief Summary.