A Decade of Immunotherapy Approvals
Ipilimumab’s approval in March 2011 was the first of its kind, but it was followed by a steady stream of new agents. In September 2014, the FDA approved pembrolizumab, sold as Keytruda, for melanoma. Three months later, in December 2014, nivolumab—marketed as Opdivo—received approval for the same cancer. Both drugs target the PD-1 checkpoint, a different mechanism from the one addressed by ipilimumab. Then, in May 2016, atezolizumab, marketed as Tecentriq, gained approval for bladder cancer; it targets PD-L1.
The approvals accelerated further in 2022, when the FDA cleared eight new immunotherapy indications in a single year. Those indications covered lung cancer, liver cancer, and cervical cancer. That expansion built on a foundation of more than 20 immunotherapy drug approvals since 2011. As of 2023, immunotherapies are approved for more than 20 cancer types. Among those is non-small cell lung cancer, the leading cause of cancer death in the United States. The American Cancer Society projected 238,000 new cases of lung cancer in 2023. With immunotherapy now available for that disease, patients and doctors have new treatment options.
The Accelerated Pathway’s Role in Expanding Access
Many of these immunotherapy approvals have been granted through the FDA’s accelerated approval pathway. That process allows treatments to reach the market sooner than they would under traditional review, based on evidence that suggests a clinical benefit. In exchange for earlier access, companies are required to conduct post-market studies to confirm that the benefit is real. The pathway emerged from the FDA’s broader mandate to ensure the safety and effectiveness of drugs before they reach patients, but it was designed to balance that mandate with the urgency of unmet medical needs.
The FDA, a federal agency within the U.S. Department of Health and Human Services, enforces the Federal Food, Drug, and Cosmetic Act and also carries out duties under the Public Health Service Act. It operates field offices across the states and territories, and after 2008 it placed staff in some foreign countries to support its oversight. Its decisions about which drugs to approve—and under what conditions—directly determine the therapies available to Americans fighting cancer. For some cancers, the accelerated pathway has meant that patients can receive new drugs years before traditional clinical trials would have concluded.
Ongoing Monitoring and Future Outlook
The post-market studies required by the accelerated approval pathway remain a key area of attention. The FDA continues to monitor the safety and efficacy of these treatments after they enter widespread use. The agency’s oversight ensures that the earlier access granted to patients is backed by continued evidence.
As more immunotherapy drugs gain approval and as new indications are added, the landscape of cancer treatment in the United States continues to evolve. Patients with cancers that once had few options now have multiple immunotherapy choices. The FDA’s accelerated approval pathway has been the vehicle for many of these advances, though its conditions require companies to keep studying their drugs.
For readers, the practical implication is that treatment options have expanded significantly since 2011. Consulting a doctor remains the essential step for any individual considering immunotherapy. The FDA’s actions shape the timeline of when new therapies become available and what evidence must be gathered after their release. The agency’s role, grounded in its public health mission, remains central to this ongoing transformation in cancer care.
The American Cancer Society’s projection of new lung cancer cases in 2023 underscores the stakes. With immunotherapy now approved for that leading cause of cancer death, the potential impact is substantial. The approvals keep coming, and the FDA continues to evaluate new data, fulfilling its mandate to protect and promote public health through the oversight of medicines that reach the U.S. market.
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