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Oncology Drug Approvals in 2016


In 2016, the Office of Hematology and Oncology Products of the U.S. Food and Drug Administration (FDA) approved a number of new molecular entities, indications, and tests. The most notable were drug approvals in disease areas such as non–small cell lung cancer, myeloma, head and neck cancer, and breast cancer. Herewith is a list of the new agents, indications, and tests approved during 2016.

  • Rucaparib (Rubraca): for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)–associated advanced ovarian cancer who have been treated with two or more chemotherapies. Rucaparib is a poly (ADP ribose) polymerase (PARP) inhibitor. Approved December 19, 2016.
  • FoundationFocus CDxBRCA test: a next-generation sequencing–based companion diagnostic approved in conjunction with the approval of rucaparib, to identify patients with advanced ovarian cancer eligible for treatment with the drug. The test detects alterations in BRCA1 and BRCA2 genes in the tumor tissue of patients with ovarian cancer. Approved December 19, 2016.
  • Daratumumab (Darzalex): in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Daratumumab is a CD38-directed cytolytic antibody. Approved November 21, 2016.
  • Nivolumab (Opdivo): for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. Nivolumab is a programmed cell death protein 1 (PD-1)–blocking antibody. Approved November 10, 2016.
  • Pembrolizumab (Keytruda): for the treatment of patients with metastatic non–small cell lung cancer whose tumors express programmed cell death ligand 1 (PD-L1) as determined by an FDA-approved test. Pembrolizumab is a PD-1–blocking antibody. Approved October 24, 2016.
  • Olaratumab (Lartruvo): for the treatment of patients with soft-tissue sarcoma not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an anthracycline-containing regimen is appropriate. Olaratumab is a platelet-derived growth factor receptor alpha (PDGFR-alpha)–blocking antibody. Approved October 19, 2016.
  • Atezolizumab (Tecentriq): for the treatment of patients with metastatic non–small cell lung cancer whose disease has progressed during or following platinum-containing chemotherapy. Atezolizumab is a PD-L1–blocking antibody. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on an FDA-approved therapy for these aberrations prior to receiving atezolizumab. Approved October 18, 2016.
  • Erlotinib (Tarceva): indication modified for the treatment of non–small cell lung cancer, in particular, to limit its use to patients whose tumors have specific EGFR mutations. Erlotinib is a kinase inhibitor. Modified October 18, 2016.
  • Nivolumab (Opdivo): dosage for the currently approved indications in renal cell carcinoma, metastatic melanoma, and non–small cell lung cancer modified to 240 mg intravenously every 2 weeks. Nivolumab is a PD-1–blocking antibody. Modified September 13, 2016.
  • Pembrolizumab (Keytruda): for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. Pembrolizumab is a PD-1–blocking antibody. Approved August 5, 2016.
  • Cobas EGFR Mutation Test v2: using plasma specimens as a companion diagnostic test for the detection of exon 19 deletions or exon 21 substitution mutations in the EGFR gene, to identify patients with metastatic non–small cell lung cancer eligible for treatment with erlotinib. Approved June 1, 2016.
  • Atezolizumab (Tecentriq): for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Atezolizumab is a PD-L1–blocking antibody. Approved May 18, 2016.
  • Nivolumab (Opdivo): for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and posttransplantation brentuximab vedotin (Adcetris). Nivolumab is a PD-1–blocking antibody. Approved May 17, 2016.
  • Lenvatinib (Lenvima): in combination with everolimus (Afinitor), for the treatment of patients with advanced renal cell carcinoma following one prior antiangiogenic therapy. Lenvatinib is a kinase inhibitor and was first approved in 2015 for the treatment of locally recurrent or metastatic, progressive, radioactive iodine–refractory differentiated thyroid cancer. Approved May 13, 2016.
  • Cabozantinib (Cabometyx): for the treatment of advanced renal cell carcinoma in patients who have received prior antiangiogenic therapy. Cabozantinib is a kinase inhibitor. Approved April 25, 2016.
  • Venetoclax (Venclexta): for the treatment of patients with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. Venetoclax is a BCL-2 inhibitor. Approved April 11, 2016.
  • Defibrotide (Defitelio): for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic stem cell transplantation. Defibrotide is an anticoagulant. Approved March 30, 2016.
  • Crizotinib (Xalkori): for the treatment of patients with metastatic non–small cell lung cancer whose tumors are ROS1-positive. Crizotinib is a kinase inhibitor. Approved March 11, 2016.
  • Everolimus (Afinitor): for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin with unresectable, locally advanced, or metastatic disease. Everolimus is a kinase inhibitor. Approved February 26, 2016.
  • Obinutuzumab (Gazyva): for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma who have relapsed after, or are refractory to, a rituximab (Rituxan)-containing regimen. Obinutuzumab, a CD-20–directed cytolytic antibody, was first approved in 2013 for use in combination with chlorambucil (Leukeran) in the treatment of patients with previously untreated chronic lymphocytic leukemia. Approved February 26, 2016.
  • Palbociclib (Ibrance): for use in combination with fulvestrant (Faslodex) for the treatment of women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. Palbociclib is a kinase inhibitor. Approved February 19, 2016.
  • Eribulin (Halaven): for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. Approved January 28, 2016.
  • Ofatumumab (Arzerra): for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was first approved in 2009 for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab (Campath). Approved January 19, 2016.

For more information, visit www.fda.gov. ■

Source: U.S. FDA: Hematology/Oncology (Cancer) Approvals & Safety Notifications. http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm279174.htm. Accessed January 12, 2017.



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