The Journal of Hematology Oncology Pharmacy is pleased to provide readers the Second Annual Oncology Pharmacy Guide to New FDA Approvals. The goal of this Guide is to offer payers, oncology/hematology pharmacists, and other healthcare stakeholders a comprehensive review of novel oncology/hematology drugs that were approved by the US Food and Drug Administration (FDA) in the previous year, including a listing of all the new indications, new combinations, new formulations, and new patient populations for oncology drugs approved by the FDA in 2016. This practical, detailed, and evidence-based resource is intended to help guide payers and pharmacists in their clinical and benefit design decision-making.
Of the total of 22 new drugs approved in 2016 by the FDA, new hematology/oncology drugs took first place, with 7 new molecular entities (NMEs) and biologic licensing applications (BLAs) approved in 2016. Furthermore, 2016 saw the introduction of many novel biologics and novel molecules becoming available for patients for the first time ever.
An important trend seen in 2016 was the FDA approval of multiple and important new indications for oncology/hematology drugs already on the market for different types of cancer. For example, atezolizumab (Tecentriq) was first approved in May 2016 for the treatment of patients with bladder cancer, and then in October 2016, it received a new indication for lung cancer. Similarly, nivolumab (Opdivo), which was initially approved in 2015, received 3 new indications in 2016; in January 2016, it was approved, in combination with ipilimumab (Yervoy), for unresectable or metastatic melanoma; in May 2016, it was approved for Hodgkin lymphoma; and in November 2016, it was approved for recurrent or metastatic squamous-cell head and neck cancer. Many other cancer drugs received new indications, often for a new type of cancer, and sometimes for multiple types of cancer.
Moreover, based on the new FDA approvals in the first quarter of 2017, cancer drugs will likely continue to dominate the FDA approval process this year. By mid-March, the FDA approved 2 novel cancer drugs and 4 new indications for cancer drugs already on the market.
On February 28, 2017, the FDA approved telotristat ethyl (Xermelo), a tryptophan hydroxylase inhibitor, for patient with carcinoid syndrome diarrhea, a rare condition; on March 13, 2017, ribociclib (Kisqali), a CDK4/CDK6 inhibitor, was approved for the first-line treatment of metastatic breast cancer.
As for new indications, on January 19, 2017, ibrutinib (Imbruvica) became the first nonchemotherapy drug to be approved for marginal zone lymphoma; on February 2, 2017, nivolumab (Opdivo) became the second treatment for bladder cancer approved in the past 12 months; on February 22, 2017, lenalidomide (Revlimid) was approved as maintenance therapy after autologous stem-cell transplantation; and on March 14, 2017, pembrolizumab (Keytruda) was approved for classical Hodgkin lymphoma.
Similar to last year, this Guide includes a comprehensive directory of all the hematology oncology NMEs and BLAs approved by the FDA in 2016 for a variety of cancers, as well as a list of all new indications, combinations, dosages, dosage forms, formulations, patient populations, and new blood products.
In addition, this year’s Guide also includes comprehensive updates on some of the new drugs and important new indications for cancer approved in 2016 and early 2017.
We hope this Guide serves as a useful tool in applying up-to-date information on new pharmaceuticals into clinical decisions and patient care, and encourages further dialog related to innovation in drug development.