ODAC Rejects Rociletinib in Lung Cancer
April 12th 2016The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-1 against the accelerated approval of rociletinib as a treatment for patients with metastatic EGFR T790M–mutated non–small cell lung cancer (NSCLC) who have previously received an EGFR-targeted therapy.
CAR T-cells Rapidly Evolving as Cancer Therapies
March 20th 2016Chimeric antigen receptor-modified T-cell therapies have demonstrated durable complete responses for patients with relapsed/refractory B-cell acute lymphoblastic leukemia; however, several questions remain regarding their optimal use and applicability outside of this disease.
FDA Approves New Melphalan Formulation in Myeloma
March 15th 2016The 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.
Cetuximab Improves Long-Term Control in HPV-Negative Head and Neck Cancer
February 22nd 2016Among 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.
HPV+ Oropharyngeal Cancer Recurrence Typically Detected Within 6 Months of Treatment
February 19th 2016In 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.
FDA Grants Durvalumab Breakthrough Designation for Bladder Cancer
February 19th 2016The 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.
Surgical gene therapy study for wet AMD yields mixed results
February 15th 2016In 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.
FDA Grants T-Cell Therapy Breakthrough Designation in Sarcoma
February 9th 2016An 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.
Second-Line Cabozantinib Shows Rare Survival Advantage in RCC
February 1st 2016The 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.
Allogeneic CAR T-Cell Therapy Shows Promising Efficacy Without GVHD
January 29th 2016Treatment 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.
LUX-Lung 7 Trial Demonstrates Efficacy of Afatinib Over Gefitinib
January 29th 2016Second-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.
Lenvatinib/Everolimus Combo Submitted for Approval in Advanced RCC
January 15th 2016Regulatory 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.