NCCN Guidelines Favor Cancer Drugs Granted Regular Approval

Cancer drugs that are granted accelerated approval are less likely than drugs with regular approval to be given high-level evidence ratings and preferred status in National Comprehensive Cancer Network (NCCN) guidelines, according to research published in JAMA Network Open.

Researchers evaluated 100 drugs with 315 cancer indications to analyze how the drugs were included in NCCN guidelines.

The researchers sought to identify any differences between drugs granted accelerated approval and those granted regular approval from the US Food and Drug Administration.

As of October 2022, there were 156 indications that initially had regular approval and 159 that initially had accelerated approval. Of the indications that were initially granted accelerated approval, 78 (49%) were converted to regular approval during the study period, 60 (38%) still had accelerated approval at last follow-up, and 21 (13%) had their approval withdrawn.

Across all indications, the most common NCCN category of evidence was 2A (n=185), followed by category 1 (n=105), category 2B (n=6), and category 3 (n=2). The remaining 17 indications were removed or excluded from the guidelines.

About half of indications (n=153) were classified as “preferred,” 5 were “alternative preferred,” 55 were “other recommended,” and 38 were “useful in certain circumstances.” The remaining 47 indications did not have a preference listed.

Indications with accelerated approval were significantly less likely than indications with regular approval to receive category 1 recommendations — 3% and 47%, respectively (P <.001) — or to be categorized as preferred — 40% and 58%, respectively (P =.008).

Category 1 recommendations were significantly less common for indications that still had accelerated approval than for indications that had accelerated approval converted to regular approval — 3% and 38%, respectively (P <.001). However, preferred status was similar between these groups — 40% and 47%, respectively (P =.61).

For indications that had accelerated approval withdrawn, 38% (8/21) remained in the NCCN guidelines, despite the guidelines being updated after the withdrawals. One indication — romidepsin for T-cell lymphoma — was listed as a preferred treatment option.

“This cross-sectional study found that cancer drug indications with accelerated approval had lower evidence and treatment preference ratings in the NCCN guidelines than indications with regular approval from the FDA; however, even among drugs with regular approval, most indications were supported by lower-level evidence,” the researchers pointed out. “Greater clarity regarding the NCCN thresholds and definitions of level of evidence may make the NCCN guidelines more useful to clinicians, patients, and payers.”

Reference

Cliff ERS, Rome RS, Kesselheim AS, Rome BN. National Comprehensive Cancer Network guideline recommendations of cancer drugs with accelerated approval. JAMA Netw Open. Published online November 14, 2023. doi:10.1001/jamanetworkopen.2023.43285

This article originally appeared on Cancer Therapy Advisor