Welcome to the Third Annual Oncology Guide to New FDA Approvals

2018 Third Annual Oncology Guide to New FDA Approvals

The Lynx Group is pleased to bring you the Third Annual Oncology Guide to New FDA Approvals. The goal of this Guide is to offer oncologists, pharmacists, oncology nurses, and other healthcare stakeholders a comprehensive overview of new hematology oncology drugs approved by the US Food and Drug Administration (FDA) in 2017. This practical tool offers a quick, yet detailed, evidence-based resource for oncology providers to guide their management of patients with cancer.

In addition to a complete and detailed list of all the new molecular entities (NMEs) and new biologic licensing applications (BLAs) approved by the FDA in 2017 for cancer, this Guide provides a comprehensive list of new indications, new formulations, new patient populations, and the full scope of new oncology-related drug approvals in the United States. This year’s Guide introduces a new category—gene therapies—ushering in the new world of gene therapies into the US market. Of the first 3 gene therapies approved, the first 2 were for cancer (see "Kymriah (Tisagenlecleucel) for Young Patients with Acute Lymphoblastic Leukemia: First FDA-Approved Gene Therapy" and "Yescarta (Axicabtagene Ciloleucel) Second CAR T-Cell Therapy Approved for Patients with Certain Types of Large B-Cell Lymphoma").

In the words of FDA Commissioner Scott Gott­lieb, MD, the approval of the first gene therapies marked a new milestone in drug development, opening new possibilities for curing cancer and other diseases. “We are entering a new frontier in medical innovation with the ability to program a patient’s own cells to attack a deadly cancer,” Dr Gottlieb said. “New technologies such as gene therapies and cell therapies hold out the potential to transform medicine” ("Kymriah (Tisagenlecleucel) for Young Patients with Acute Lymphoblastic Leukemia: First FDA-Approved Gene Therapy").

The year 2017 marked a new direction in the FDA drug approvals: by intensifying its accelerated review process and priority review, the FDA reached a 21-year high, says Dr Owens in his Introduction to this Guide ("FDA Approvals in 2017 Represent a 21-Year High"), which reviews the entire scope of FDA drug approvals in 2017, not only in oncology. As Dr Owens notes, oncology drugs constituted a large share of FDA approvals in 2017. Overall, 46 NMEs and new BLAs were approved by the FDA in 2017 in all clinical categories—a doubling of the 22 NMEs and BLAs approved in 2016.

By applying its fast track review, using its breakthrough therapy designation and the accelerated and/or priority review pathways to approve many of the new drugs, the FDA allows pharmaceutical companies to continue their research and development of life-saving medications, while giving patients earlier access to such therapies.

New technologies continue to feature high in today’s drug development, with the ongoing introduction of new and improved biologic therapies, immunotherapies, and targeted therapies, while simultaneously making use of new testing and screening technologies to match the right patient with the right treatment. Therefore, the number of first-in-class drugs continues to grow, and many of the new drugs entering the market receive new indications soon after, in quick succession.

As in previous years, a key feature of this Guide is the comprehensive Directory of all hematology oncology NMEs and BLAs approved by the FDA in 2017, as well as a list of all new indications, combinations, formulations, dosages, dosage forms, patient populations, biosimilars, and gene therapies ("FDA Approvals of Brand-Name Prescription Cancer Drugs in 2017").

This Guide also includes a select sample of comprehensive updates on some of the key new oncology drugs or new indications approved by the FDA in 2017.

We hope you find this publication a useful tool for applying up-to-date information on new pharmaceuticals within your clinical decisions and patient care.

Editor's Note

The FDA continues to make changes to the prescribing information of many drugs on an ongoing basis. Every effort has been made to update the information in each drug update and in any other sections of this publication, based on each drug’s prescribing information up to February 28, 2018. The individual comprehensive drug updates were independently developed by the editors based on publicly available information. The Publisher is not responsible for any inaccuracies stemming from changes, new approvals, or updates that became available later in the year. Readers are advised to review the prescribing information for any future updates and revisions.

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