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.

FDA Approves Inotuzumab for Adults with B-Cell Acute Lymphoblastic Leukemia
- By NCI Staff
- September 18, 2017
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
- By NCI Staff
- September 14, 2017
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
- By Edward Winstead
- September 11, 2017
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
- By NCI Staff
- August 28, 2017
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
- By NCI Staff
- August 23, 2017
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
- By NCI Staff
- August 17, 2017
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
- By NCI Staff
- August 11, 2017
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
- By NCI Staff
- July 25, 2017
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
- By NCI Staff
- July 21, 2017
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
- By NCI Staff
- July 18, 2017
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.