The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers of these products. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use and the product can be marketed in the United States.
The following anticancer therapeutics have recently received FDA approval.
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December 21, 2018: The molecularly targeted therapeutic tagraxofusp-erzs is the first ever treatment approved by the FDA for the treatment of blastic plasmacytoid dendritic cell neoplasm. |
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December 20, 2018: The FDA approval of calaspargase pegol-mknl provides a longer-acting chemotherapy option for certain patients with acute lymphoblastic leukemia (ALL). |
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December 19, 2018: Certain patients with Merkel cell carcinoma, a rare and aggressive form of skin cancer, have a second immunotherapy option with the FDA’s recent approval of pembrolizumab for the disease. |
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November 28, 2018: The FDA approval of gilteritinib provides a new treatment option for certain patients diagnosed with acute myeloid leukemia (AML). |
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November 26, 2018: The FDA recently announced it has approved the first molecularly targeted therapeutic for use based on whether a patient’s tumor tests positive for a specific genetic biomarker and not where in the body the tumor originated. |
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November 21, 2018: The FDA has approved two molecularly targeted therapeutics for treating patients newly diagnosed with acute myeloid leukemia (AML) who are 75 or older. |
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November 9, 2018: Many liver cancer patients have a second immunotherapy treatment option with the FDA approval of pembrolizumab for certain patients with the most common form of the disease. |
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November 2, 2018: The molecularly targeted therapeutic lorlatinib has received FDA approval for the treatment of certain patients with non-small cell lung cancer, making it the fifth targeted therapy for ALK-positive lung cancer. |
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October 16, 2018: The FDA has approved a new therapeutic that targets ADP-ribose polymerase (PARP) proteins in patients with metastatic or locally advanced, HER2-negative breast cancer who have an inherited cancer-associated BRCA1 or BRCA2 mutation. |
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September 28, 2018: The immunotherapy cemiplimab-rwlc is the first-ever treatment approved by the FDA specifically for treating squamous cell carcinoma. |
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September 27, 2018: The FDA has added a fifth molecularly targeted therapeutic option for the treatment of lung cancer driven by EGFR mutations. |
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September 24, 2018: The FDA has approved a new molecularly targeted therapeutic called duvelisib for treating certain patients with is intended for patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma. |
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September 13, 2018: The FDA has approved the first of a new type of molecularly targeted therapy for use in treating certain patients with a rare type of leukemia. |
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August 27, 2018: The combination of ibrutinib and rituximab as a new treatment for Waldenström’s macroglobulinemia, a rare form of non-Hodgkin lymphoma, has been approved by the FDA. |
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August 16, 2018: The FDA has approved expanding the use of lenvatinib, a molecularly targeted therapeutic, to treat certain patients with the most common type of liver cancer. |
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August 16, 2018: The FDA has expanded the use of the immunotherapeutic nivolumab, an immune checkpoint inhibitor, to treat certain patients with small cell lung cancer. |
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August 8, 2018: The FDA has approved a new immunotherapeutic for treating two types of cutaneous T-cell lymphoma, mycosis fungoides and S?zary syndrome. |
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July 30, 2018: The FDA has approved a new targeted radiotherapeutic for treating two rare neuroendocrine tumors, pheochromocytomas and paragangliomas. |
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July 20, 2018: The new therapeutic was approved by the FDA for treating patients whose leukemia tests positive for a mutation in the IDH1 gene. |
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July 10, 2018: The combination of ipilimumab and nivolumab was approved by the FDA for metastatic colorectal cancer that is positive for certain genetic biomarkers. |
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June 27, 2018: The FDA has approved a third combination of targeted therapeutics for treating patients who have metastatic melanoma with certain gene mutations. |
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June 22, 2018: An FDA-approved precision medicine treatment is for certain patients with metastatic lung cancer with a specific BRAF mutation. |
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June 13, 2018: The FDA has expanded the use of the immune checkpoint inhibitor pembrolizumab to treat patients with primary mediastinal large B-cell lymphoma, a type of non-Hodgkin lymphoma. |
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June 12, 2018: The FDA has expanded the use of the immunotherapeutic pembrolizumab to treat certain patients with cervical cancer. |
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May 4, 2018: The FDA has approved a combination of molecularly targeted therapeutics for treating patients who have anaplastic thyroid cancer that cannot be removed by surgery or that has metastasized, and that tests positive for a BRAF V600E gene mutation. |
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May 1, 2018: The FDA decision means tisagenlecleucel (Kymriah) is now approved for certain types of non-Hodgkin lymphoma and acute lymphoblastic leukemia. |
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April 16, 2018: The FDA has approved a combination of the immunotherapeutics ipilimumab and nivolumab for treating intermediate- or poor-risk advanced renal cell carcinoma that was previously untreated. |
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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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February? 14, 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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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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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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January 5, 2018: The FDA approved expanding the use of the molecularly targeted therapeutic denosumab to include the prevention of bone complications in patients with multiple myeloma. |
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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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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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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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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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September 22, 2017: The FDA decision means the immune checkpoint inhibitor nivolumab is now approved for eight types of cancer. |
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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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September 18, 2017: The FDA approved the molecularly targeted therapeutic copanlisib for the treatment of certain adults with follicular lymphoma. |
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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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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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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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May 18, 2017: With this announcement, the immune checkpoint inhibitor pembrolizumab is now approved for five forms of cancer. |