TRIM: 8 x 10.75”

A NEW TREATMENT OPTION FOR PATIENTS WITH METASTATIC EGFR T790M tools MUTATION-POSITIVE NSCLC, AS DETECTED BY AN FDA-APPROVED TEST, WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY

INDICATION TAGRISSO is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Approved Drugs liposarcoma who have received a prior granted breakthrough therapy designation IMPORTANT SAFETY INFORMATION anthracycline-containing regimen. to its investigational third-generation • The U.S. Food and Drug Administration epidermal growth factor receptor (EGFR) • There are no contraindications for TAGRISSO (FDA) has approved Arzerra® (ofatumumab) • The FDA has approved Ibrance® mutant-specific tyrosine kinase inhibitor • Interstitial Lung Disease (ILD)/Pneumonitis occurred in 3.3% and was fatal in 0.5% of 813 TAGRISSO Injection (Novartis Pharmaceuticals (palbociclib) Capsules (Pfizer, Inc., pfizer.com) (TKI), BI 1482694 (HM61713). patients. Withhold TAGRISSO and promptly investigate for ILD in any patient presenting with worsening Corporation, novartis.com) for extended in combination with fulvestrant for the of respiratory symptoms indicative of ILD (e.g., dyspnea, cough and fever). Permanently discontinue treatment of patients who are in complete treatment of women with hormone receptor • Merck (merck.com) announced that the TAGRISSO if ILD is confirmed or partial response after at least two lines of (HR)-positive, human epidermal growth FDA has approved its sNDA for single-dose therapy for recurrent or progressive chronic factor receptor 2 (HER2)-negative advanced or Emend® (fosaprepitant dimeglumine) for • QTc interval prolongation occurred in TAGRISSO patients. Of the 411 patients in two Phase II studies, 0.2% lymphocytic leukemia (CLL). Arzerra was metastatic breast cancer with disease injection, in combination with other were found to have a QTc greater than 500 msec, and 2.7% had an increase from baseline QTc greater previously approved for the treatment of progression following endocrine therapy. antiemetic medicines, for the prevention of than 60 msec. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc previously untreated patients with CLL for delayed nausea and vomiting in adults syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to whom fludarabine-based therapy was • (amgen.com) announced that the receiving initial and repeat courses of prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval considered inappropriate and also for FDA has approved the supplemental new moderately emetogenic chemotherapy. prolongation with signs/symptoms of life threatening arrhythmia patients with CLL refractory to fludarabine drug application (sNDA) of Kyprolis® and alemtuzumab. (carfilzomib) for Injection in combination • AstraZeneca (astrazeneca.com) • Cardiomyopathy occurred in 1.4% and was fatal in 0.2% of 813 TAGRISSO patients. Left Ventricular Ejection with dexamethasone or with lenalidomide announced that the FDA has granted Fraction (LVEF) decline >10% and a drop to <50% occurred in 2.4% of (9/375) TAGRISSO patients. Assess • Teikoku Pharma USA, Inc. (teikokuusa. plus dexamethasone for the treatment of breakthrough therapy designation for LVEF before initiation and then at 3 month intervals of TAGRISSO treatment. Withhold TAGRISSO if ejection com) announced that the FDA has approved patients with relapsed or refractory multiple durvalumab (MEDI4736), for the treatment fraction decreases by 10% from pretreatment values and is less than 50%. For symptomatic congestive heart Docetaxel Injection, non-alcohol formula myeloma who have received one to three of patients with PD-L1 positive inoperable or failure or persistent asymptomatic LV dysfunction that does not resolve within 4 weeks, permanently for the treatment of breast cancer, non-small lines of therapy. The FDA also approved metastatic urothelial bladder cancer whose discontinue TAGRISSO cell lung cancer, prostate cancer, gastric Kyprolis as a single agent for the treatment tumor has progressed during or after one • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use adenocarcinoma, and head and neck cancer. of patients with relapsed or refractory standard platinum-based regimen. multiple myeloma who have received one or effective contraception during TAGRISSO treatment and for 6 weeks after the final dose. Advise males with • The FDA has approved NextSource more lines of therapy. • The FDA has granted breakthrough therapy female partners of reproductive potential to use effective contraception for 4 months after the final dose Biotechnology’s (nextsourcebio.com) designation to PKC412 (midostaurin) • The most common adverse reactions (>20%) observed in TAGRISSO ® Gleostine (lomustine) 5 mg capsules, • Bristol-Myers Squibb (bms.com) (Novartis, novartis.com) for adults with patients were diarrhea (42%), rash (41%), dry skin (31%) and nail toxicity (25%) and it is now commercially available in the announced that the FDA has granted newly-diagnosed AML who are FLT3 mutation- D9291 is. AZ .. U.S. Gleostine is approved for use as a single accelerated approval to Opdivo® positive, as detected by an FDA-approved Please see Brief Summary of complete Prescribing Information. agent treatment or in combination with () in combination with Yervoy® test, and who are eligible to receive standard other approved chemotherapeutic agents. (ipilimumab) for the treatment of patients induction and consolidation chemotherapy. Gleostine is indicated to treat brain with BRAF V600 wild-type and BRAF V600 tumors—both primary and metastatic, as mutation-positive unresectable or meta- • The FDA has granted to the NOW well as Hodgkin’s disease. static melanoma. new drug application (NDA) for (AbbVie, abbvie.com) for the treatment of Visit TAGRISSOhcp.com for more information APPROVED! • Eisai Co., Ltd. (eisai.com) announced Drugs in the News CLL in adults who have received at least one that the FDA has approved Halaven® prior therapy, including patients with 17p (eribulin) Injection for the treatment of • Boehringer Ingelheim (us.boehringer- deletion. . O patients with unresectable or metastatic ingelheim.com) announced that the FDA has ..n S TAGRISSO is a trademark of the AstraZeneca group of companies. ow TAGRIS ©2015 AstraZeneca. All rights reserved. 3150425 11/15

18 accc-cancer.org | March–April 2016 | OI

3150425_3182206_Tagrisso_Oncology Issues.indd 1 12/11/15 7:52 AM