FDA Approvals

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable.

New drugs and certain biologics must be proven safe and effective to FDA’s satisfaction before companies can market them in interstate commerce. Manufacturers must also prove they are able to make the drug product according to federal quality standards.

FDA experts review the results of laboratory, animal, and human clinical testing done by medical product manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.

The following anticancer therapeutics have recently received FDA approval. Summaries were originally posted to the AACR blog, Cancer Research Catalyst.


Groundbreaking New Immunotherapy Approved for Acute Lymphoblastic Leukemia (ALL)

August 30, 2017: In a much anticipated milestone for the oncology community, the FDA announced the first approval of a type of immunotherapy known as CAR T-cell therapy.
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Targeting HER2-positive Breast Cancer

July 17, 2017: The FDA approved a new HER2-targeted therapeutic for the treatment of certain patients with early-stage breast cancer.
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Targeting Tumors Based on a Biomarker

May 23: 2017: The FDA’s approval for the immunotherapeutic pembrolizumab is the first based entirely on a tumor biomarker rather than the site where the cancer originated.
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Immunotherapeutic Use Expanded to Bladder Cancer

May 18, 2017: With this announcement, the immune checkpoint inhibitor pembrolizumab is now approved for five forms of cancer.
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