​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​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.

The Immunotherapeutic Durvalumab Recently Got FDA Approval for Stage 3 Lung Cancer

February​ 23, 2018: The FDA expanded the use of the checkpoint inhibitor to the treatment of patients with stage 3 lung cancer whose cancer cannot be removed surgically and has not progressed following concurrent treatment with platinum-based chemotherapy and radiotherapy.
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A New Hormone Therapy Markedly Delays the Spread of Prostate Cancer

February​ 20, 2018: The ​FDA recently approved the antihormone agent apalutamide for treating men with nonmetastatic prostate cancer that has stopped responding to standard antihormone treatments.
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A Targeted Radiotherapy Approved for Neuroendocrine Tumors

February​ 12, 2018: ​The armamentarium for oncologists treating patients with gastroenteropancreatic neuroendocrine was expanded with the FDA's approval of a new radiotherapeutic .
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First Targeted Therapeutic for BRCA-mutant Breast Cancer Approved

January 12, 2018: The FDA has approved the molecularly targeted therapeutic olaparib ​for treating certain patients with metastatic, HER2-negative breast cancer.
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Vemurafenib Becomes First FDA-approved Treatment for a Rare Type of Blood Cancer​

November 28, 2017: The FDA has approved the molecularly targeted therapeutic vemurafenib​ for treating certain adults who have a rare type of blood cancer called Erdheim-Chester disease.
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New BTK-Targeted Therapeutic Approved for Non-Hodgkin Lymphoma

November 6, 2017: The FDA has approved the molecularly targeted therapeutic acalabrutinib (for treating adults who have an aggressive form of non-Hodgkin lymphoma called mantle cell lymphoma.
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Second CAR T–cell Therapy Gets Approved by the FDA

October 24, 2017: The FDA has approved the second of a revolutionary new type of immunotherapy known as chimeric antigen receptor (CAR) T–cell therapy to treat adults with certain types of non-Hodgkin lymphoma.
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New Treatment Option for Breast Cancer Gets FDA Approval

October 2, 2017​: The FDA has added a molecularly targeted therapeutic, abemaciclib, to the armamentarium for oncologists treating patients with breast cancer.
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Expanding the Use of an Immunotherapeutic to Liver Cancer

September 22, 2017: The FDA decision means the immune checkpoint inhibitor nivolumab is now approved for eight types of cancer.
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Use of Immunotherapeutic Expanded to Stomach (Gastric) Cancer

September 18, 2017: The FDA has approved the checkpoint inhibitor pembrolizumab for the treatment of certain patients with advanced stomach ​cancer.
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New Molecularly Targeted Therapeutic Approved for Non-Hodgkin Lymphoma

September 18, 2017: The FDA approved the molecularly targeted therapeutic copanlisib for the treatment of certain adults with follicular lymphoma.
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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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