This issue highlights the many ground-breaking therapies approved by the U.S. Food and Drug Administration over the course of 2015. Highlights include immunotherapies, new treatment options for breast cancer patients, and financial assistance options for cancer patients.
Immunotherapies declared game-changers, swept approvals in 2015
Breakthrough therapies for blood, lung and skin cancers dominated 2015 oncology approvals. There were 17 new oral and infusion approvals, with 10 expanded indications for drugs approved prior to 2015. Only eight new drugs and one expanded indication were approved in 2014, representing a 200 percent increase in just one year.
Immunotherapies swept the approvals, with Bristol-Myers Squibb’s nivolumab and Merck Oncology’s pembrolizumab, previously approved for melanoma, adding indications for non-small cell lung cancer and renal cell carcinoma over the course of the year.
“2015 really established a new line of therapy for, essentially, the vast majority of non-small cell lung cancer patients, and that was immunotherapy,” said Dr. Mark Socinski, Director of the Lung Cancer Section of the Divison of Hematology/Oncology at the University of Pittsburgh School of Medicine. “These approvals created choices, and from that perspective, 2015 was a monumental year.”
Of 50 oncologists surveyed by MedPage Today, 37 cited immunotherapy drugs as “game-changers” in 2015. Checkpoint inhibitors spread into new tumor types heralded new thinking about ways in which certain cancers can be treated, while also showing promise for more difficult types of cancers.