Biologics’ mid-year report provides a comprehensive look into the specialty pharmacy landscape and current trends. Within oncology specifically, the FDA has approved eight new therapies and three new indications for therapies currently in market to date in 2015.
2015 approvals to date cover multiple indications, mechanisms of action
Eight new orals have been approved in the oncology space in 2015 year to date, with three new indications for previously approved therapies. The approvals span multiple indications, routes of administration and mechanisms of action, and include orphan and breakthrough therapies.
“The continued development of effective therapeutics based on our understanding of cancer biology and the ability through the use of biomarkers to personalize therapies have lead to further expand options for patients across multiple malignancies,” said Dr. Mark Socinski, Director, Lung Cancer Section, Division of Hematology/Oncology at the University of Pittsburgh.
Ibrutinib was approved in February 2015 for the treatment of patients with Waldenstrom’s macroglobulinemia (WM). This is the first therapy ever approved for the treatment of this rare, B-cell lymphoma. Ibrutinib has also been approved for patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer received a new first line treatment for their disease when palbociclib was approved in February 2015. ER-positive, HER2-negative is the most common subtype, representing around 60 percent of the advanced breast cancer population.