Not many newly approved cancer drugs replace existing standard-of-care therapies: JAMA
USA: There has been a high volume of new cancer drug approvals, despite this, only about 14% of these drugs displace the current standard-of-care therapy, says a recent study. This suggests that newer drugs may benefit patients with few alternatives but could be a burden to the cost of care because competition in the drug market is critical to lowering drug prices. The study appears in JAMA Network Open.
Although many cancer drugs in oncology and malignant hematology receive US Food and Drug Administration (FDA) approval each month, it is not clear how many of these cancer drugs transform the treatment landscape significantly by tumor group. In particular, it remains unclear how many of these newly approved cancer drugs displace the existing standard-of-care therapies for their indication vs being added to existing therapies.
Against the above background, David J. Benjamin, University of California, Irvine, Orange, and colleagues aimed to examine how many cancer drugs displace the standard-of-care therapies vs being added to existing therapy or filling breaks in systemic treatments in the metastatic setting, adjuvant setting, or maintenance setting.
For this purpose, the researchers performed a retrospective cross-sectional study using landmark trials leading to FDA approval of cancer drugs between May 1, 2016, and May 31, 2021. All FDA approvals for cancer drugs between May 1, 2016, and May 31, 2021, were evaluated using the DA Oncology (Cancer)/Hematologic Malignancies Approval Notifications website. The researchers examined all clinical trials leading to FDA approval of cancer drugs during this period.
By evaluating the comparator arm (or lack thereof) in the clinical trial, a drug was determined to have displaced the prior standard-of-care therapy leading to the drug's approval and also by reviewing National Comprehensive Cancer Network Guidelines. Cancer drug approvals were divided as a) first-line displacing if a drug was approved for use in the first-line setting and displaced the prior standard-of-care drug for an indication; b) first-line drug alternatives/new if a drug was approved for use in the first-line setting but did not displace the standard of care at the time of approval or was a new drug that was first of its class for an approved indication; c) add on if a drug was approved in combination with a previously approved therapy for a disease or if a drug was approved for use in the adjuvant or maintenance settings; and d) later line if a drug was approved for use in the second-, third-, or later-line settings.
Following were the key findings of the study:
- Between May 1, 2016, and May 31, 2021, there were 207 FDA cancer drug approvals in oncology and malignant hematology. Of these 207 approvals, 28 drugs (14%) were first-line displacing therapies.
- A total of 32 drugs (15%) were first-line drug alternatives/new drugs.
- A total of 61 drugs (29%) were add-on therapies. Finally, 86 drugs (42%) were approved as later-line therapies.
"In this study, most cancer drug approvals between 2016 and 2021 were in the later-line settings as opposed to displacing the current standard-of-care therapy for the approved indication," wrote the authors. "These later-line drugs may benefit patients with few alternatives but add to the cost of care because competition in the drug markets is a key factor in leading to lower drug prices."
Reference:
Benjamin DJ, Xu A, Lythgoe MP, Prasad V. Cancer Drug Approvals That Displaced Existing Standard-of-Care Therapies, 2016-2021. JAMA Netw Open. 2022;5(3):e222265. doi:10.1001/jamanetworkopen.2022.2265
KEYWORDS: cancer, cancer treatment, cancer therapy, FDA approved, newly approved drugs, cost of care, standard of care, cancer drugs, JAMA, David J Benjamin
