News

The FDA has approved Captisol-enabled melphalan (Evomela) as a high-dose conditioning treatment for use in patients with multiple myeloma prior to autologous stem cell transplantation, as well as for the palliative treatment of patients with myeloma for whom oral therapy is not appropriate.

Chimeric antigen receptor-modified T-cell therapies continue to demonstrate promising signs of efficacy for patients with hematologic malignancies, including those with acute lymphoblastic leukemia and non-Hodgkin lymphoma.

Among patients with HPV-negative, locoregionally advanced head and neck squamous cell carcinoma with a poor prognosis, adding cetuximab (Erbitux) to induction chemotherapy and hyperfractionated or accelerated chemoradiation therapy produced long-term control.

In patients treated with definitive radiation therapy for HPV-positive oropharyngeal squamous cell carcinoma, most recurrences can be detected via imaging at 3 months and physical examinations during the first 6 months after treatment.

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational human IgG1 monoclonal antibody durvalumab (MEDI4736) for patients with inoperable or metastatic urothelial bladder cancer that is programmed-cell-death-ligand 1 (PD-L1)-positive and refractory to platinum-based treatment.

In a phase IIa study of patients with neovascular age-related macular degeneration, a single subretinal injection of rAAV.sFlt-1 gene therapy demonstrated acceptable safety, but not a complete or durable anti-VEGF response. Additional preclinical research is under way.

An affinity enhanced T-cell therapy has received an FDA breakthrough therapy designation for the treatment of patients with inoperable or metastatic pretreated synovial sarcoma who harbor HLA-A*201, HLA-A*205, or HLA-A*206 alleles and whose tumors express the NY-ESO-1 tumor antigen.

The second interim analysis of the phase III METEOR trial has revealed a statistically significant improvement in overall survival with cabozantinib (Cometriq) versus everolimus as a treatment for patients with advanced renal cell carcinoma following progression on one prior therapy.

Three-year follow-up from the phase I/IIa trial of rAAV.sFlt-1 subretinal injection is encouraging for gene therapy for exudative age-related macular degeneration.

Treatment with allogeneic anti–CD19 chimeric antigen receptor–modified T cell therapy induced complete remissions in 30% of patients with advanced progressive B-cell malignancies without causing graft-versus-host disease.

Second-generation, EGFR-directed therapy afatinib (Gilotrif) may be superior to first-generation gefitinib (Iressa) in reducing the risk of disease progression and treatment failure in first-line treatment of patients with EGFR mutation-positive, advanced non-small cell lung cancer.

The FDA has granted a priority review designation to cabozantinib as a treatment for patients with advanced renal cell carcinoma following progression on one prior therapy.

Nivolumab has improved overall survival versus investigator's choice of therapy for patients with platinum-refractory squamous cell carcinoma of the head and neck in the phase III CheckMate-141 trial.

A new combination therapy for treating advanced renal cell carcinoma (RCC) is showing promise in early clinical testing and may soon be approved the US Food and Drug Administration (FDA).

The FDA has granted a priority review designation to the combination of lenvatinib and everolimus as a treatment for patients with metastatic renal cell carcinoma following one prior VEGF-targeted therapy.

Regulatory filings have been submitted in the United States and Europe for the combination of lenvatinib and everolimus as a treatment for patients with metastatic renal cell carcinoma following a VEGF-targeted therapy.

PD-1 and PD-L1 inhibitors, including nivolumab, atezolizumab, and avelumab, will likely play a major role as the backbone of combination therapy for patients with renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BI 1482694, which is an investigational third-generation, epidermal growth factor receptor (EGFR), mutant-specific tyrosine kinase inhibitor (TKI) for patients with non-small cell lung cancer (NSCLC).

Researchers compared the B cells of patients with multiple sclerosis and healthy patients, specifically examining granulocyte macrophage colony stimulating factor (GM CSF), in order to determine their role in interactions between other immune cells within MS.

A new drug application has been submitted for cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy.

The FDA has granted a breakthrough therapy designation to the third-generation EGFR TKI BI-1482694 as a potential treatment for patients with EGFR T790M-positive non–small cell lung cancer.

Frederick Locke, MD, discusses the potential for KTE-C19 in non-Hodgkin lymphoma.

The targeted, oral therapy crizotinib (Xalkori), has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have c-ros oncogene 1 (ROS1)-rearranged tumors.

Waseem Qasim, MBBS, PhD, and his team began researching a novel strategy to enable “off-the-shelf”’ therapy with mismatched donor chimeric antigen receptor (CAR)19 T cells.

The combination of radiation therapy plus cetuximab had higher rates of acute toxicity among patients with locally advanced squamous cell carcinoma of the head and neck compared with radiation therapy plus cisplatin.

Two CD19-targeted chimeric antigen receptor-modified T-cell therapies demonstrated complete response rates ranging from 90% to 100% in patients with high-risk acute lymphoblastic leukemia.

Updated findings from early stage clinical trials exploring chimeric antigen receptor-modified T-cell therapies continue to highlight the effectiveness of these approaches for patients with non-Hodgkin lymphoma.

Two-year event-free survival increased from 52% with conventional therapy to 65% with the addition of rituximab among patients with newly diagnosed, CD20-positive Philadelphia (Ph)-chromosome negative B-cell precursor acute lymphoblastic leukemia, according to results from a phase III trial.

Chimeric antigen receptor T cells can eradicate large burdens of multiple myeloma, according to a new study presented at ASH.

Gene therapy has the potential to deliver long-lasting remissions for patients with advanced B-cell malignancies who already have undergone an allogeneic hematopoietic stem cell transplant.