ubmslateCN-logo-ubm

CN Mobile Logo

Search form

Topics:

FDA Drug Approvals for Cancer in 2016

FDA Drug Approvals for Cancer in 2016

  • On January 19 the US Food and Drug Administration (FDA) approved ofatumumab (Arzerra) as a maintenance therapy for patients with recurrent or progressive chronic lymphocytic leukemia (CLL). The drug was previously approved for untreated patients for whom fludarabine-based therapy was considered inappropriate and for those refractory to fludarabine and alemtuzumab. Image courtesy of Novartis.
  • On January 28 the FDA approved eribulin (Halaven) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. Image courtesy of Eisai.
  • On February 19 the FDA approved palbociclib (Ibrance) in combination with fulvestrant for the treatment of women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer whose diseased progressed following endocrine therapy. Image courtesy of Pfizer.
  • On February 26 the FDA approved obinutuzumab (Gazyva) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen. Image courtesy of Genentech.
  • On February 26 the FDA approved everolimus (Afinitor) for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors of gastrointestinal or lung origin with unresectable, locally advanced or metastatic disease. Image courtesy of Novartis.
  • On March 11 the FDA approved crizotinib capsules (Xalkori) for the treatment of patients with metastatic non–small-cell lung cancer whose tumors are ROS1-positive. Image courtesy of Pfizer.
  • On March 30 the FDA approved defibrotide sodium (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. Image courtesy of Jazz Pharmaceuticals.
  • On April 25 the FDA approved cabozantinib (Cabometyx) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. Image courtesy of Exelixis.
  • On April 11 the FDA approved venetoclax (Venclexta) for the treatment of patients with chronic lymphocytic leukemia with a 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. Image courtesy of AbbVie.
  • On May 13 the FDA approved lenvatinib capsules (Lenvima), in combination with everolimus, for the treatment of advanced renal cell carcinoma following one prior anti-angiogenic therapy. Image courtesy of Eisai.
  • On May 17 the FDA granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin. Image courtesy of Bristol-Myers Squibb.
  • On May 18 the FDA gave accelerated approval to the anti–PD-L1 antibody 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. Image courtesy of Genentech.
  • On August 5 the FDA granted accelerated approval to pembrolizumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. Image courtesy of Merck.
  • On October 18 the FDA approved atezolizumab (Tecentriq) for the treatment of patients with metastatic non–small-cell lung cancer whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab. Image courtesy of Genentech.
  • On October 19 the FDA granted accelerated approval to 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. Image courtesy of Eli Lilly and Company.
  • On October 24 the FDA approved pembrolizumab (Keytruda) for the treatment of patients with metastatic non–small-cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test. Image courtesy of Merck.
  • On November 10 the FDA approved 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. Image courtesy of Bristol-Myers Squibb.
  • On November 21 the FDA approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Image courtesy of Janssen Biotech.
  • On December 6 the FDA expanded the approval for bevacizumab (Avastin) either in combination with carboplatin and paclitaxel or carboplatin and gemcitabine chemotherapy, followed by bevacizumab alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Image courtesy of Roche.

By clicking Accept, you agree to become a member of the UBM Medica Community.