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# Improve Cancer Checkpoint Inhibitor Development: Pazdur
- URL: https://www.fdaweb.com/improve-cancer-checkpoint-inhibitor-development-pazdur/
- Published: 2021-12-16T12:00:00.000Z
- Updated: 2026-09-14T17:26:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150793

The development of checkpoint inhibitors needs more coordination and collaboration and less competition. That’s the view of FDA Oncology Center of Excellence director **Richard Pazdur** and chief of medical oncology **Julia Beaver**, writing in the *New England Journal of Medicine*.

Checkpoint inhibitors are a type of immunotherapy that works by blocking different checkpoint proteins. They treat cancers such as melanoma and lung cancer.

“The unbridled and rapid growth of checkpoint inhibitors has led to a Wild West of drug development, featuring a stampede of commercial sponsors, clinical trials, and redundant development plans,” Pazdur and Beaver [write](https://www.nejm.org/doi/full/10.1056/NEJMp2116863?ref=fdaweb.com) (subscription or purchase required). “FDA can encourage collaboration through programs such as Project Orbis and multistakeholder meetings, but it has limited ability to compel sponsors to work together. Competitive commercial interests may frequently trump cooperation.”

The article suggests that efforts to corral the enthusiasm for checkpoint inhibitors should focus on international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti-PD-1 and anti-PD-L1 antibodies rather than developing me-too drugs.

“Sponsors making claims about developing a ‘better’ checkpoint inhibitor should directly compare their agent with those that are already approved,” Pazdur and Beaver write. “Unfortunately, there is no evidence that such randomized trials are under way.”

The article concludes that greater attempts to harmonize diagnostics, regulatory submissions, and multinational trial designs would help optimize resource use. “FDA has advocated for such efforts with limited success,” it says. “Duplicative development programs may erode the resources available for innovation, and innovation is one of the motivations for patients to participate in clinical trials. Harnessing these redundant efforts will lead to greater efficiency in drug development, not only reducing development costs, but also protecting our most vital resources — patients and their confidence in the clinical trial system.”