Most New Cancer Drug Approvals Have Not Displaced Standards of Care

Most New Cancer Drug Approvals Have Not Displaced Standards of Care

Numerous cancer drug approvals in recent years have led some to refer to the modern era of cancer treatment as “the golden age of oncology.” Even at the height of the global pandemic, the US Food and Drug Administration (FDA) approved more new cancer medicines than during the prior year. This is great news for patients and oncologists, but the question remains as to how many of these new therapies displace the existing standards of care for their indication vs simply providing an alternative treatment option. Dr David J. Benjamin and colleagues sought to answer this question and also evaluate how many new therapies were combined with older therapies over a 5-year period.

In this cross-sectional study, the authors reviewed the 207 FDA oncologic/hematologic malignancy drugs that were approved between May 2016 and May 2021. Of these, only 1 in 6 (n = 28; 14%) were first-line therapies that displaced standard-of-care therapies. Examples included alectinib and osimertinib for non-small-cell lung cancer, atezolizumab and bevacizumab for liver cancer, and cabozantinib for advanced kidney cancer. Most of the approvals (42%; 86 therapies) were drugs for use in the second-line or later-line settings. Because most of these were studied in single-arm trials or vs placebo, they did not displace other therapies upon their approvals. Thirty-two drugs (15%) were new therapies and/or alternatives to first-line therapies, but did not displace the existing standard of care, and 61 drugs (29%) were approved as add-on therapies with previously approved therapies or for use in the maintenance and adjuvant settings.

There were disparities among drug approvals by tumor type, with lung-related tumors receiving the most approvals (n = 37), followed by genitourinary tumors (n = 28), leukemia (n = 25), lymphoma (n = 22), breast cancer (n = 19), gastrointestinal cancers (n = 14), and others. Four approvals were in the tumor agnostic setting: 2 neurotrophic tyrosine receptor kinase inhibitors and 2 approvals for the anti–PD-1 drug pembrolizumab, all for second-line use and later.

High level
The authors suggest enthusiasm for the high number of cancer drug approvals should be considered in the context of their use. While having more treatment options is an improvement, further research and development in oncology are needed before there are significant changes to the treatment landscape.

Ground level
Cancer drug approvals give community oncologists and their patients more options, although in recent years many do not provide market competition. These new drugs are an important advancement for patients with few alternatives, but the total cost of care and potential delays in palliative care should be factored into treatment decisions.