FDA Grants Accelerated Approval to Brigatinib for ALK-Positive NSCLC
On April 28, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
FDA Expands Regorafenib Indications for Patients with HCC
On April 27, 2017, the U.S. Food and Drug Administration (FDA) expanded the indications of regorafenib to include the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
The Case of the Immunotherapy Inquiry
Jay is a 62-year-old man with newly diagnosed, stage IIIA (T3, N1), unresectable, non-small cell lung cancer (NSCLC) that tested negative for ALK, EGFR, and KRAS mutations. Additionally, PD-L1 (programed death receptor ligand) expression was less than 30%. Jay is symptomatic with a persistent cough, unintentional weight loss, and fatigue.
What Oncology Nurses Need to Know About Immunotherapy Agents
As immunotherapeutic options for cancer treatments continue to grow, oncology nurses need a deeper understanding of the therapies, how they work, and how to manage their side effects, so they can continue to provide the best patient care.
FDA Broadens Palbociclib Indication in Breast Cancer
On March 31, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to palbociclib for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women.
FDA Grants Regular Approval to Osimertinib for EGFR T790 Mutation-Positive NSCLC
On March 30, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to osimertinib for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
Recent FDA-Approved Drugs Offer More Options for NSCLC and Other Cancers
The end of 2016 proved to be a busy and exciting time for cancer breakthroughs, seeing eight new U.S. Food and Drug Administration (FDA) approvals for immunotherapy and biotherapy. Following is a summary of cancer-related FDA approvals in the last quarter of 2016, indications for treatment, and associated clinical implications.
FDA Approves Niraparib for Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On March 27, 2017, the U.S. Food and Drug Administration (FDA) approved niraparib, a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
FDA Approves Avelumab for Treatment of Patients With Metastatic Merkel Cell Carcinoma
On March 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio, EMD Serono, Inc.) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer.
FDA Approves Pembrolizumab for Refractory or Relapsed Classical Hodgkin Lymphoma
On March 14, 2017, The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.
FDA Approves Ribociclib for Breast Cancer Treatment
On March 13, 2017, the U.S. Food and Drug Administration (FDA) approved ribociclib (KISQALI®, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Safety Procedures for Live-Virus Immunotherapeutic Cancer Vaccines
Therapeutic vaccines represent a new way of fighting tumors by stimulating a patient’s immune system to attack cancer cells. The U.S. Food and Drug Administration (FDA) has currently approved two of these types of vaccines: sipuleucel-T for metastatic prostate cancer and talimogene laherparepvec for metastatic melanoma. However, many other cancer vaccines are being investigated in clinical trials.
FDA Approves Lenalidomide as Maintenance Therapy for Patients With Multiple Myeloma
On February 22, 2017, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid®, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.
Advancements in Immunotherapy, Genetics Lead ASCO’s Annual Progress Report
Every year, oncology research marches toward new, innovative treatments for patients with cancer. Cancer research is a cumulative process—building upon itself year after year—but, with time, major changes begin to make their way into practices across the country. Some of these advancements stand to change the face of cancer treatment for years to come. In a field of constant evolution, oncology nurses and their colleagues need to stay abreast of developments in science and technology as new knowledge is uncovered in the treatment of cancer.
FDA Approves Nivolumab for Advanced or Metastatic Bladder Cancer
On February 2, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for 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 a platinum-containing chemotherapy.