FDA Approvals - Cancer Currents Blog
News on recent approvals of cancer therapies by the Food and Drug Administration. Includes expert comments on how the approval will influence patient care and future research.
- Immunotherapy Drug Cemiplimab Approved for Advanced Squamous Cell Skin Cancer
The Food and Drug Administration approved the immunotherapy drug cemiplimab (Libtayo) for an advanced form of cutaneous squamous cell carcinoma (SCC), a common type of skin cancer. It is the first agent to be approved specifically for advanced SCC.
- Moxetumomab Approved by FDA for Hairy Cell Leukemia
The FDA has approved moxetumomab pasudotox (Lumoxiti), a bacterial toxin–based drug, for the treatment of some patients with hairy cell leukemia (HCL). Moxetumomab is approved to treat patients with HCL who have already undergone at least two lines of standard treatments.
- Ribociclib Approval Expanded for Some Women with Advanced Breast Cancer
FDA has expanded the approved uses of ribociclib (Kisqali) for women with advanced breast cancer, including new uses in pre- and postmenopausal women. It’s the first approval under a new FDA program to speed the review of cancer drugs.
- Targeted Drug Approved for Acute Myeloid Leukemia with IDH1 Gene Mutations
The FDA has approved ivosidenib (Tibsovo) for the treatment of adults with acute myeloid leukemia (AML) that has a specific mutation in a gene called IDH1. Ivosidenib becomes the first FDA-approved IDH1-targeted treatment.
- Combination of Immunotherapy Drugs Approved for Metastatic Colorectal Cancer
The FDA has approved the combination of the immune checkpoint inhibitors ipilimumab (Yervoy) and nivolumab (Opdivo) for the treatment of patients with metastatic colorectal cancer whose tumor cells have defects that affect their ability to repair DNA.
- New Immunotherapy Option Approved for Cervical Cancer, Rare Lymphoma
FDA has approved pembrolizumab (Keytruda) for some women with advanced cervical cancer and some patients with primary mediastinal large B-cell lymphoma (PMBCL), a rare type of non-Hodgkin lymphoma.
- FDA Alters Approved Use of Two Checkpoint Inhibitors for Bladder Cancer
FDA has changed the approved uses of the immunotherapy drugs pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to treat the most common form of bladder cancer. The change is based on whether patients’ tumors have a specific biomarker.
- Approval Expanded for Venetoclax in Chronic Lymphocytic Leukemia
FDA expanded the approval of venetoclax (Venclexta) for people with chronic lymphocytic leukemia (CLL) to include those whose cancer has progressed after previous treatment, regardless of whether their cancer cells have the deletion 17p gene alteration.
- Dabrafenib–Trametinib Combination Approved for Melanoma, Anaplastic Thyroid Cancer
FDA recently approved the targeted-drug combination to treat patients with advanced melanoma and a subset of patients with a rare and aggressive form of thyroid cancer whose tumors have a specific mutation in the BRAF gene.
- FDA Approves Second CAR T-Cell Therapy for Lymphoma
FDA has approved tisagenlecleucel (Kymriah) for certain kinds of non-Hodgkin lymphoma. Read about the trial that led to the approval and what the approval means for people with lymphoma.
- FDA Approves Nivolumab and Ipilimumab Combination for Advanced Kidney Cancer
FDA has approved the combination of two immunotherapy drugs, nivolumab (Opdivo) and ipilimumab (Yervoy), as an initial treatment for some patients with advanced kidney cancer. Learn how this approval will affect patient care.
- Rucaparib Approved as Maintenance Treatment for Some Recurrent Ovarian Cancers
FDA has expanded its approval of rucaparib (Rubraca) as a maintenance therapy for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer whose tumors shrank after subsequent treatment with a platinum-based chemotherapy.
- Abemaciclib Approval Expands Initial Treatment Options for Advanced Breast Cancer
FDA has approved the CDK4/6 inhibitor abemaciclib (Verzenio) as a first-line treatment in some women with advanced or metastatic breast cancer. Under the approval, the drug must be used in combination with an aromatase inhibitor.
- FDA Approves Apalutamide for Some Men with Prostate Cancer
In the trial that led to the approval, apalutamide (Erleada) delayed cancer metastasis for men with prostate cancer that is resistant to androgen deprivation therapy.
- Cabozantinib Approval Expands Initial Treatment Options for Advanced Kidney Cancer
The Food and Drug Administration has approved cabozantinib (Cabometyx®) as an initial treatment for patients with advanced renal cell carcinoma, the most common type of kidney cancer.
- Abiraterone Approved for Earlier Use in Men with Metastatic Prostate Cancer
The Food and Drug Administration (FDA) has expanded the approval of abiraterone (Zytiga®) for men with prostate cancer. The agency approved abiraterone, in combination with the steroid prednisone, for men with metastatic prostate cancer that is responsive to hormone-blocking treatments (also known as castration-sensitive) and is at high risk of progressing.
- FDA Approves New Treatment for Certain Neuroendocrine Tumors
People with cancerous neuroendocrine tumors (NETs) that affect the digestive tract now have a new treatment option. On January 29, FDA approved the targeted treatment lutetium Lu 177 dotatate (Lutathera®) for adult patients with advanced NETs that affect the pancreas or gastrointestinal tract.
- Olaparib Approved for Treating Some Breast Cancers with BRCA Gene Mutations
The drug olaparib (Lynparza®) is the first treatment approved by the Food and Drug Administration for patients with metastatic breast cancer who have inherited mutations in the BRCA1 or BRCA2 genes.
- Nilotinib Can Be Discontinued in Some Patients with Chronic Myelogenous Leukemia
On December 22, FDA approved an update to the label of nilotinib (Tasignia) that states that some patients with CML who are taking nilotinib and whose cancer has been in remission for an extended period can safely stop taking it.
- Genomic Profiling Tests Cleared by FDA Can Help Guide Cancer Treatment, Clinical Trial Enrollment
The FDA has recently approved two tests to identify genetic alterations in tumors. One of the tests can be used to identify patients who may be candidates to receive specific targeted therapies.
- Brentuximab Vedotin Approved for Two Rare Lymphomas
FDA has approved brentuximab vedotin (Adcetris®) for the treatment of adults who have been treated previously for either primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides, two rare lymphomas that start as rashes on the skin.
- Acalabrutinib Receives FDA Approval for Mantle Cell Lymphoma
The FDA has granted accelerated approval to acalabrutinib (Calquence®) for the treatment of adults with mantle cell lymphoma whose cancer has progressed after receiving at least one prior therapy.
- FDA Approves Alectinib For Initial Treatment of ALK-Positive Lung Cancer
FDA has approved alectinib (Alecensa) as a first-line treatment option for patients with advanced non-small cell lung cancer that is ALK positive. Alectinib is the third ALK inhibitor to be approved in this setting.
- Dasatinib Approved by FDA for Some Children with Chronic Myelogenous Leukemia
On November 9, the FDA approved dasatinib (Sprycel®) for the treatment of children with chronic myelogenous leukemia (CML) whose cancer cells express the Philadelphia chromosome and whose disease is in a relatively early stage, known as the chronic phase.
- Abemaciclib Approved by FDA for Advanced or Metastatic Breast Cancer
FDA approved abemaciclib (Verzenio™) for the treatment of some people with advanced or metastatic HR-positive, HER2-negative breast cancer whose disease has progressed after treatment with hormone therapy.
- With FDA Approval for Advanced Lymphoma, Second CAR T-Cell Therapy Moves to the Clinic
One month after approving the first CAR T-cell therapy for cancer, FDA has approved a second such therapy. The treatment, axicabtagene ciloleucel (Yescarta™), was approved for some patients with advanced non-Hodgkin lymphoma.
- Nivolumab Receives Accelerated Approval from FDA for Advanced Liver Cancer
The FDA has granted accelerated approval to the immunotherapy drug nivolumab (Opdivo®) for patients with advanced liver cancer who have previously been treated with the targeted therapy sorafenib (Nexavar®).
- Pembrolizumab Secures FDA Approval in Stomach Cancer
The FDA has granted accelerated approval to the immunotherapy drug pembrolizumab (Keytruda®) for use in patients with advanced gastric (stomach) cancer that is PD-L1 positive.
- Gemtuzumab Receives New FDA Approval for Acute Myeloid Leukemia
FDA has approved gemtuzumab ozogamicin (Mylotarg™) for adults with newly diagnosed CD33-positive AML and patients 2 years and older with CD33-positive AML who have experienced a relapse or whose disease has not responded to initial treatment.
- FDA Expands Approval of Fulvestrant for Advanced Breast Cancer
FDA has expanded its approval of fulvestrant (Faslodex®) as a standalone treatment for postmenopausal women with advanced HR-positive, HER2-negative breast cancer who have not previously undergone endocrine therapy.
- FDA Approves Inotuzumab for Adults with B-Cell Acute Lymphoblastic Leukemia
FDA has approved inotuzumab (Besponsa®) for some adults with B-cell acute lymphoblastic leukemia (ALL). The approval covers patients with B-cell ALL whose disease has relapsed or is refractory to standard chemotherapy.
- FDA Approves Olaparib as Maintenance Therapy for Recurrent Ovarian Cancer
FDA has granted regular approval to olaparib tablets (Lynparza®) as maintenance treatment for patients with recurrent ovarian cancer who are having partial or complete responses to platinum-based chemotherapy.
- CAR T-Cell Therapy Approved for Some Children and Young Adults with Leukemia
FDA has approved tisagenlecleucel (Kymriah™), a type of immunotherapy called CAR T-cell therapy, for some children and young adults with advanced acute lymphoblastic leukemia (ALL).
- Two New Therapies Approved for Acute Myeloid Leukemia
FDA has approved two new treatments for some adult patients with acute myeloid leukemia (AML): enasidenib (Idhifa®), which targets the IDH2 protein; and liposomal cytarabine-daunorubicin CPX-351 (Vyxeos®), a two-drug chemotherapy combination encapsulated in liposomes.
- Neratinib Approved by FDA for HER2-Positive Breast Cancer
FDA has approved neratinib for patients with early-stage HER2-positive breast cancer who have finished at least 1 year of adjuvant therapy with trastuzumab.
- FDA Approves Nivolumab for Some Metastatic Colorectal Cancers
FDA has granted accelerated approval to the immunotherapy drug nivolumab (Opdivo®) for patients with metastatic colorectal cancer whose tumors have alterations that affect DNA repair.
- Ibrutinib Becomes First FDA-Approved Drug for Chronic Graft-Versus-Host Disease
A drug used to treat several blood cancers, ibrutinib, has been approved by FDA to treat chronic graft-versus-host disease, making it the first approved therapy for this potentially fatal side effect of cancer-related stem cell transplants.
- FDA Grants Full Approval to Blinatumomab for Acute Lymphoblastic Leukemia
FDA changed its accelerated approval of blinatumomab (Blincyto) for some patients with acute lymphoblastic leukemia to a full approval and expanded the approved indications for its use.
- FDA Clears Wider Use of Cooling Cap to Reduce Hair Loss during Chemotherapy
The FDA has cleared a cooling cap—a device designed to reduce hair loss during chemotherapy called the DigniCap Scalp Cooling System—for use by patients with any type of solid tumor.
- Two-Drug Combination Approved for Lung Cancers with BRAF Mutations
FDA approved the combination of dabrafenib (Tafinlar®) and trametinib (Mekinist®) for the treatment of metastatic non-small cell lung cancer (NSCLC) that has an alteration in the BRAF gene called the V600E mutation.
- New Rituximab Formulation Approved for Some Lymphomas, Leukemia
The FDA has approved a new formulation of rituximab, Rituxan Hycela, that reduces treatment administration time for patients with several types of blood cancer.
- FDA Expands Approval of Ceritinib for ALK-Positive Non-Small Cell Lung Cancer
The FDA has approved the targeted therapy ceritinib as an initial treatment for patients with lung cancer that has a mutation in the ALK gene.
- FDA Approves Pembrolizumab for Tumors with Specific Genetic Features
FDA approved pembrolizumab for patients with solid tumors that have specific genetic features, called mismatch repair deficiency and high microsatellite instability. This is the first approval based on a genetic feature, rather than cancer type.
- FDA Expands Approval of Pembrolizumab for First-Line Treatment of Non-Small Cell Lung Cancer
FDA approved the immune checkpoint inhibitor pembrolizumab to be used with chemotherapy as a first-line treatment for non-small cell lung cancer.
- Midostaurin Approved by FDA for Acute Myeloid Leukemia
The FDA has approved midostaurin for patients with newly diagnosed acute myeloid leukemia (AML) with mutations in the FLT3 gene. The approval also covers several rare conditions.
- FDA Approves Immunotherapy Drugs for Patients with Bladder Cancer
The FDA has approved four immunotherapy drugs—avelumab, atezolizumab, durvalumab, and pembrolizumab—for the treatment of patients with bladder cancer. All four drugs belong to a class of cancer therapies known as checkpoint inhibitors.
- Regorafenib Becomes First FDA-Approved Drug for Liver Cancer in Nearly a Decade
FDA approved the kinase inhibitor regorafenib for some patients with hepatocellular carcinoma, the most common form of liver cancer.
- FDA Grants Brigatinib Accelerated Approval for Metastatic Non-Small Cell Lung Cancer
On April 28, the FDA granted accelerated approval to the targeted therapy brigatinib (Alunbrig™) for patients with metastatic non-small cell lung cancer (NSCLC) and alterations in the ALK gene whose cancer has progressed during their initial therapy.