New Anticancer Medications
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In 2013 there were 27 new molecular entities approved and 10 were for the treatment of cancer. This reflects the trend in recent years for approval of a disproportionate number of oncology drugs compared with non-oncology drugs. The trend may be a byproduct of the FDA Modernization Act of 1997, which provides for easier drug approval for conditions with unmet medical needs. It allows for a fast track process including an expedited 6 month New Drug Application review that requires only one high quality study for approval. Adding to the faster approval process is the fact that research data submitted for oncology drugs are often less rigorous than for other drugs (e.g., studies with smaller sample size, often with no blinding and/or no control group, and a lower level of statistical significance).
Currently, FDA approval of oncology drugs is based on clinical studies that involve the site of the cancer (eg, breast cancer, lung cancer). This may change in the future because scientists now understand that the behavior of a cancer – and how it responds to treatment – are dependent on the molecular pathways that drive cancer cell growth, rather than the location of the cancer in the body. The new cancer czar Richard Pazdur has suggested that the FDA approval process for future oncology drugs be based on studies targeting specific malfunctioning molecular growth pathways, rather than the site of the cancer.
This issue reviews oncology drugs by cancer site as is still the standard, covering 6 recently approved agents for the 4 most common cancers: lung, prostate, breast, and colorectal cancer. The drugs' role in therapy, side effects, and (for oral agents) pertinent patient counseling points are summarized. Selected drug interactions are listed in Table 1. Table 2 summarizes key information for 11 additional new agents.
Community providers can facilitate access to these very expensive new drugs by helping patients identify assistance programs and/or clinical trials.
Publication Date: 01/18/2014
Expiration Date: 01/18/2017
CE Credit: 2.0 (0.20 CEU)
Type of Activity: Knowledge-based
This program was developed by The Rx Consultant and published by Continuing Education Network, Inc.
The Rx Consultant accepts no advertising or financial support from the pharmaceutical industry and
is funded solely by the purchase of programs. The Rx Consultant is dedicated to providing unbiased,
balanced information to health care practitioners.
Programs developed by The Rx Consultant are written by health care providers with expertise in the topic
area, peer-reviewed, extensively edited, and fact-checked. This development process was created to insure
that every program presents information that is current, accurate, relevant to "real world" health care
providers, and written in an easy reading, "plain English" style.
James Chan, PharmD, PhD and Pamela Mausner, MD
Dr. James Chan and Dr. Pamela Mausner report no financial or personal relationship with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this issue.
This accredited program is targeted to pharmacists and nurses.
Goals & Objectives
At the conclusion of this program, participants will be able to:
For each of the drugs reviewed:
- List the FDA approved indication(s), discuss the evidence supporting approval, and discuss the role(s) in therapy.
- Describe significant side effects and drug interactions. For oral agents, provide 2-3 patient counseling tips.
- For each drug listed in Table 2: List the generic name, brand name, route of administration, and FDA approved indication(s).
The Rx Consultant is a publication of Continuing Education Network, Inc.
Continuing Education Network, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education as a
provider of continuing pharmacy education.
Continuing Education Network is approved by the California Board of Registered Nursing, Provider Number CEP 13118. Programs approved by CA BRN are accepted by most State Boards of Nursing.
ACPE Universal Activity Number: 0428-0000-14-003-H04-P
Exam & Credit Statement Procedures
Upon successful completion of this program and the post test (70%), 2.0 hours of continuing education credit will be awarded. To receive credit and your exam score, please complete the exam questions and
Editorial and Review Board
Chief Editor and CE Administrator
Terry M. Baker, PharmD
Tracy Farnen, PharmD
James Chan, PharmD, PhD
Pharmacy Quality and Outcomes Coordinator
Associate Clinical Professor
School of Pharmacy
University of California San Francisco
San Francisco, CA
Richard Ron Finley, B.S. Pharm.,R.Ph.
Clinical Pharmacist (volunteer faculty)
University of California, San Francisco (UCSF) Memory and Aging Center
Lecturer (Emeritus) UCSF, Department of Clinical Pharmacy
Health Sciences Clinical Professor, UCSF School of Pharmacy
San Francisco, CA
Ray Dolby Brain Health Center, Sutter Health/CPMC
San Francisco, CA
Consult Pharmacist Aging and Adult Health Services
San Francisco Health Department
San Francisco, CA
Julio R. Lopez, PharmD, FCSHP
Chief of Pharmacy Service
VA Northern California Health Care System
Adjunct Clinical Professor
College of Pharmacy
Assistant Clinical Professor
School of Pharmacy
University of California, San Francisco
San Francisco, CA Adjunct Professor
Thomas J. Long School of Pharmacy
University of the Pacific
Visiting Associate Professor and Lecturer
Samuel Merritt University
Pamela Mausner, MD
Helen Berlie, Pharm.D. CDE, BCACP
Clinical Assistant Professor, Pharmacy Practice
Wayne State University
Ambulatory Care Specialist - Diabetes
Health Centers Detroit Medical Group
Senior Editorial Advisor
Gerard Hatheway, PharmD, PhD
Belinda M. Danielson, RPh
Christopher M. DeSoto, PharmD
Angie S. Graham, PharmD
Cynthia Chan Huang, PharmD, MBA
Fred Plageman, PharmD
Editorial Advisor and Clinical Practice Consultant for Nurse Practitioners
Meuleman, RN, C, MS
About the Rx Consultant
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educate patients about drugs and manage drug therapy. The reader is responsible for confirming
the information presented here and interpreting it in relation to each patient's specific situation before utilizing the information.
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