​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​FDA Approvals

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 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.


First Targeted Therapeutic Based on Tumor Biomarker Gets FDA Approval

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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Targeting BRCA-mutant Breast Cancer With a PARP Inhibitor

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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A New Immunotherapeutic Approved for Common Skin Cancer

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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A New Targeted Therapy Option for Lung Cancer

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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Targeting Several Blood Cancers

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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A New Type of Targeted Therapy Approved for Hairy Cell Leukemia

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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Combining Targeted Therapy and Immunotherapy for Non-Hodgkin Lymphoma

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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Increasing Liver Cancer Treatment Options

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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Expanding Immunotherapy to Small Cell Lung Cancer

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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First Immunotherapeutic for Rare Types of Non-Hodgkin Lymphoma Approved

August 8, 2018: The FDA has approved a new immunotherapeutic for treating two types of cutaneous T-cell lymphoma, mycosis fungoides and Sézary syndrome.
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Targeting Radiotherapy to Treat Rare Neuroendocrine Tumors

July 30, 2018: The FDA has approved a new targeted radiotherapeutic for treating two rare neuroendocrine tumors, pheochromocytomas and paragangliomas.
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A New Molecularly Targeted Therapeutic for Acute Myeloid Leukemia

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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Combining Immunotherapy for Colorectal Cancer

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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A New Targeted Therapy Combination for Melanoma

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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Combining Targeted Therapies for Lung Cancer

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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Expanding an Immunotherapeutic to an Aggressive Form of Non-Hodgkin Lymphoma

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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Use of Immune Checkpoint Inhibitor Expanded to Cervical Cancer

June 12, 2018: The FDA has expanded the use of the immunotherapeutic pembrolizumab to treat certain patients with cervical cancer.
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A Targeted Therapy Combination Approved for Certain Thyroid Cancer Patients

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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Expanding the Use of a CAR T-cell Immunotherapy

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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Combining Immunotherapy for Kidney Cancer

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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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​ 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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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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Preventing Bone Complications for Multiple Myeloma Patients

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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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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