Drug Topics - February 2009 - (Page 32)

SPECIAL REPORT ONCOLYTIC AGENTS The pipeline: Oral antineoplastic agents the drug and not give them any ﬁnancial burden.” An estimated 400 antineoplastic agents are in the drug development pipeline. Of these, approximately 25 percent are oral oncolytics. This continued a trend that began in 1998 with increased development of oral cytotoxic agents, small molecule inhibitors, and other drugs targeting the tumor micro-environment, according to a National Comprehensive Cancer Network (NCCN) task force report. The Food and Drug Administration approved oral capecitabine in 1998 and followed it with the approval of several oral small Abiraterone acetate (CB7630; Cougar Biotechnology) Class: Hormonal therapy (antiandrogen) Proposed indication: Metastatic castration-resistant prostate cancer Arzoxifene (LY353381; Eli Lilly) Class: Selective estrogen receptor modulator (SERM) Proposed indications: Locally advanced or metastatic breast cancer Axitinib (Pﬁzer) Class: Tyrosine kinase inhibitor (TKI)/VEGF inhibitor Proposed indications: Metastatic renal cell cancer (RCC), advanced pancreatic cancer, and metastatic pancreatic cancer BIBF-1120 (Vargatef; Boehringer Ingelheim) Class: Signal transduction inhibitor/VEGF inhibitor Proposed indication: Second-line for advanced, relapsed non-small cell lung cancer (NSCLC) BIBW-2992 (Tovok; Boehringer Ingelheim) Class: Tyrosine kinase inhibitor (new generation)/signal transduction inhibitor Proposed indication: NSCLC Bosutinib (SKI-606; Wyeth) Class: Kinase inhibitor Proposed indications: Philadelphia chromosome positive (Ph+) leukemias, including chronic myelogenous leukemia (CML) and acute myelogenous leukemia (AML) Cediranib (Recentin; AstraZeneca) Class: TKI/VEGF inhibitor Proposed indications: Metastatic colorectal cancer, advanced NSCLC, combination therapy for recurrent ovarian/ peritoneal/fallopian tube cancer, combination therapy for recurrent glioblastoma Celecoxib (Celebrex; Pﬁzer) Class: Cyclooxygenase-2 inhibitor Proposed indication: Combination therapy for pancreatic cancer FDA-approved as a nonsteroidal anti-in ammatory agent for multiple uses Clodronate disodium (Bonefos; Bayer Schering) Class: Bisphosphonate Proposed indications: Breast cancer, hormone refractory metastatic prostate cancer Deforolimus (ARIAD/Merck) Class: Mammalian target of rapamycin (mTOR) inhibitor/cell proliferation inhibitor Proposed indications: Soft tissue and bone sarcomas Dutasteride (Avodart; GlasxoSmithKline) Class: 5-alpha reductase inhibitor Proposed indication: Reduction of prostate cancer risk FDA-approved for treatment of symptomatic benign prostatic hypertrophy molecule inhibitors such as imatinib, ge tinib, and erlotinib through 2004. During a 7-month period in 2005 and 2006, ve additional oral agents were approved, with two more new drug applications receiving approval in 2007. Of the $45 billion oncology pharmaceutical market, approximately $6 billion is tied up in oral oncology agents, said Burt Zweigenhaft, CEO of Oncomed, a New York-based bio-oncology pharmacy. Currently, 24 oral oncolytics are in phase 3 clinical trials. Enzastaurin (LY-317615; Eli Lilly) Class: Signal transduction inhibitor Proposed indications: Glioblastoma, non-Hodgkin’s lymphoma (NHL) Fenretinide (Ortho-McNeil) Class: Retinoid Proposed indications: Hormone (estrogen and progesterone) receptor positive breast cancer, cervical cancer, bladder cancer Gimeracil/oteracil/tegafur (Taiho) Class: Antimetabolite Proposed indication: Gastric cancer Ibandronate sodium (Boniva; Roche) Class: Bisphosphonate Proposed indications: Prevention and treatment of bone metastases in breast cancer, treatment of elderly patients with early breast cancer FDA-approved for prevention and treatment of postmenopausal osteoporosis Lestaurtinib (CEP-701; Cephalon) Class: TKI, signal transduction inhibitor Proposed indications: AML expressing FLT3 mutations Midostarin (PKC-412; Novartis) Class: TKI, signal transduction inhibitor Proposed indication: AML Motesanib (AMG716; Amgen/Takeda) Class: Vascular endothelial growth factor (VEGF) inhibitor Proposed indication: Progressive NSCLC Pazopanib (Armala; GlaxoSmithKline) Class: Signal transduction inhibitor, TKI Proposed indications: Metastatic and soft tissue sarcoma, in ammatory breast cancer, metastatic renal cell cancer, NSCLC Phenoxodiol (NV-06; Marshall Edwards) Class: Signal transduction inhibitor, tNOX inhibitor Proposed indication: Recurrent epithelial ovarian cancer Triacetyluridine (PN-401; Wellstat) Class: Chemopotentiator (prodrug of the nucleoside uridine) Proposed indication: Treatment of locally advanced or metastatic unresectable pancreatic cancer Vandetanib (Zactima; AstraZeneca) Class: Dual-acting TKI Proposed indication: NSCLC XL-184 (Exelixis) Class: Signal transduction inhibitor, TKI Proposed indication: Medullary thyroid cancer ZD-4054 (AstraZeneca) Class: Endothelin receptor antagonist Proposed indication: Hormone refractory prostate cancer with or without bone metastases Tips for managing the dispensing process Huntsman Cancer Hospital pharmacy technicians Morgan Cash and Brady Olsen, along with Ross Valley pharmacy technician Amy Taylor, offer several pointers for easing the oral oncolytic dispensing process: • Plan for at least 20 minutes per prescription for telephone exchanges. • Call the insurance provider rst to determine why a claim was denied. • If a drug is not on formulary, try to work with the physician to change the regimen before giving the patient the option to pay out of pocket. • Enlist a Medicare billing service; typical cost is about $40 monthly plus a per-claim fee. • Keep the patient advised of every development; explain that the pharmacy is the middle man and keep the patient updated on the estimated time it will take to resolve the problem. • Work with the physician to obtain the proper forms, and if possible notify the pharmacy ve days in advance of the need for the oncology medication so that prior authorization can be started early. • Consider obtaining a power of attorney for regular patients so you may act on their behalf with insurers and patient assistance programs. • Consider subscribing to IndiCare (www.indicare.com) to easily identify patient assistance programs available for speci c drugs. • Become familiar with the manufacturers’ patient assistance websites and the application forms available. (Visit www.drugtopics.com or www. modernmedicine.com for more information on this topic.) 32 DRUG TOPICS Februar y 2009 W W W.D R U GTO P I C S .C O M http://www.indicare.com http://www.drugtopics.com http://www.modernmedicine.com http://www.modernmedicine.com http://WWW.DRUGTOPICS.COM

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Drug Topics - February 2009 Contents Health-System Edition Group Attempts to Resurrect Pain Care Act HSE Business Management HSE Clinical Letters Up Front Up Front in Depth Community Practice Niche Pharmacies Serve Special Populations Special Report Oral Oncology Drugs New Drugs Update 2008 Approvals OTC New Products Viewpoint

Drug Topics - February 2009

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