Welcome to the First Annual Oncology Pharmacy Guide to New FDA Approvals

2016 Oncology Pharmacy Guide to New FDA Approvals

 

The Journal of Hematology Oncology Pharmacy has published its first annual Oncology Pharmacy Guide to New FDA Approvals with the goal of providing pharmacists and other healthcare stakeholders with a comprehensive review of pharmaceuticals that were newly approved, or that received important new indications, by the US Food and Drug Administration (FDA) in the previous year. The current 2016 edition represents the first year of publication of this Guide by the Journal of Hematology Oncology Pharmacy.

This year’s Guide includes updates on many of the new drugs that were approved in 2015 and have either been recently launched or are soon to be launched; this includes new molecular entities (NMEs), new biologics, new combinations of previously approved drugs (an increasing trend in FDA approvals), and important new or expanded indications, some of which were for drugs approved for the first time only a couple of months earlier. This first edition of the Guide includes in-depth updates on 14 novel drugs and new indications approved in 2015.

In 2015, the FDA reached a new high in drug approvals, totaling 45 NMEs or novel biologic pharmaceuticals compared with 41 approvals the year before. The goal of this special feature is to provide a practical, detailed, and evidence-based resource for hematology and oncology pharmacy practitioners and other healthcare professionals to guide their patient care decisions.

In his introduction to this edition “Translation of Benchtop Science Arrives in Force, Improves Patient Care,” Val R. Adams, PharmD, FCCP, BCOP, reflects on some of the key regulatory trends that were seen in the past 12 months, such as the approval of 18 novel hematology/oncology drugs, the majority of which are targeted agents. Acknowledging the advantage of better efficacy and less toxicity with targeted therapies, Dr Adams points out that the inherent benefit lies in early identification of biomarkers that can be used to select patients who will respond to targeted treatments, which also translates to higher efficacy rates.

This is followed by a directory of all of the NMEs and biologic license applications added to the pharmaceutical options in 2015, as well as an extensive list of all of the new indications, combinations, formulations, dosages, dosage forms, and viral therapies, including the first-ever biosimilar approved by the FDA.

This first edition of the Guide also includes a review of the anticipated hematology/oncology FDA approvals in 2016. In their article titled “A Pipeline Preview of 2016 FDA Approvals in Hematology/Oncology,” Ryan Beechinor, PharmD, BCPS, CPP, and John M. Valgus, PharmD, MHA, BCOP, shed light on some of the unique characteristics of select emergent therapies expected to receive approval in 2016.

“Along with these potential new drug approvals will come continued emphasis on identifying patients who will benefit most from these emerging therapies, as well as determination of where these drugs fit into existing oncology treatment pathways,” Drs Beechinor and Valgus explain. “Although there remain many unanswered questions about the state of cancer treatment, we anticipate that the current pipeline of oncology therapeutics will provide evidence-based solutions that will continue to advance the standard of care across all types of cancers.”

The Journal of Hematology Oncology Pharmacy will continue to provide this Guide in the coming years to offer hematology and oncology pharmacy practitioners and other healthcare professionals a tool for applying up-to-date information on new pharmaceuticals into their benefit design and patient care decisions.

We welcome your feedback and suggestions. Send any comments you have to info@JHOPonline.com. This Guide is also available online at www.JHOPonline.com.

Last modified: May 18, 2016