One hundred and fifty-six. That is how many cancer immunotherapy approvals the US Food and Drug Administration had granted by the end of 2025, according to a tally from the Cancer Research Institute covering the period since 2011. In oncology drug development, the institute says, immunotherapy now leads the pack, a long way from the scientific long shot it was 14 years earlier.
The story starts in March 2011. Bristol-Myers Squibb’s Yervoy (ipilimumab) became the first checkpoint inhibitor on the market, cleared for melanoma that could not be removed by surgery or had spread. Three more followed: Opdivo, whose generic name is nivolumab, and Keytruda, or pembrolizumab, both of which block the PD-1 protein, and Tecentriq (atezolizumab), which goes after PD-L1. Drugmakers then rushed into deals to pair these agents with one another and with unrelated drug classes.
How the drugs work
Checkpoint proteins keep the immune system from overreacting. Some tumors exploit that, producing large amounts of PD-L1 to switch off the T cells sent to kill them. The NCI explains that the medicines stop checkpoint proteins from latching onto partner proteins, which removes the “off” signal and lets the T cells attack. The list of approved uses is long: lung, bladder, cervical, colon, head and neck, liver, kidney, stomach, rectal, breast and skin cancers, Hodgkin lymphoma, and any solid tumor unable to repair copying errors in its DNA.
A year-by-year count
Approvals peaked at 22 in 2024, then fell to 13 in 2025. The institute does not read that as a slowdown. Between 2019 and 2024 the field averaged roughly 17 a year, and six of the 2025 actions were accelerated approvals converted to regular status, which do not add new entries to the count. 2025 also saw anal cancer get its first immune-based treatment option.
Checkpoint inhibitors make up 120 of the 156 approvals, or 77%. Cell and gene therapies take 19 of the rest (12%). Bispecific antibodies number 13 (8%), other immune-modulating drugs 3 (2%), and there is a single oncolytic virus (1%).
One new target in 2022
Beyond PD-1, PD-L1 and CTLA-4, only one LAG-3 drug has made it through: the nivolumab and relatlimab combination Opdualag, approved for melanoma in 2022. The NCI describes it as the first immunotherapy aimed at LAG-3 and a starting treatment for advanced melanoma. Other candidate targets, TIGIT and TIM-3 among them, have yet to produce an approved drug.
The institute sees a trade-off in that concentration. Blocking PD-1 and PD-L1 has produced durable responses across a wider range of cancers than any other immunotherapy, yet patients whose disease progresses on those drugs have few checkpoint alternatives. Agonists aimed at CD40, OX40 and 4-1BB have not moved past early clinical testing.
Sources
- 2026 Cancer Immunotherapy Insights + Impact Report – Cancer Research Institute
- Charting checkpoint inhibitors – Biopharma Dealmakers (Nature)
- Immune Checkpoint Inhibitors – NCI
- CRI Cancer Immunotherapy Insights + Impact Report, summary and modality passages
