Atezolizumab Combo Approved in BRAF V600-Mutant Melanoma

The FDA has approved a new indication for atezolizumab (Tecentriq®, Genentech) in combination with cobimetinib (Cotellic®, Genentech) and vemurafenib (Zelboraf®, Genentech and Daiichi-Sankyo) for the treatment of BRAF V600-mutated advanced melanoma. The approval was granted under a supplemental Biologics License Application (sBLA) with priority review. The approval was based on data from the double-blind, international phase 3 IMspire150 trial (NCT02908672), for which 514 patients with unresecta...

Breast Cancer Chemotherapy in Older Patients With Comorbidities: Nina Tamirisa, MD

Many older patients with breast cancer have significant comorbidities, increasing the challenges of treatment. These challenges are compounded by the fact that elderly patients with multiple comorbidities are frequently excluded from participating in clinical trials, resulting in a lack of treatment data for this population. Nina Tamirisa, MD, and colleagues recently published a study in JAMA Oncology reporting that in older patients with multiple comorbidities and estrogen receptor–positive, no...

First CAR T-Cell Therapy Approved for Mantle Cell Lymphoma

The FDA has now granted accelerated approval to brexucabtagene autoleucel (TecartusTM, Kite Pharma, formerly known as KTE-X19) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). Brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, is the first CAR T-cell therapy approved for this rare type of B-cell non-Hodgkin lymphoma. Efficacy was evaluated in the multicenter, open-label phase 2 ZUMA-2 trial (NCT02601313), which enrolled 7...

Lurbinectedin for Small-Cell Lung Cancer: Luis Paz-Ares, MD

Last month, the FDA granted accelerated approval to lurbinectedin (ZepzelcaTM, Pharma Mar, S.A.) for adults with metastatic small-cell lung cancer experiencing disease progression on or after platinum-based chemotherapy. In this interview, Luis Paz-Ares, MD, principal investigator of the phase 2 basket trial PM1183-B-005-14 (Study B-005; NCT02454972), on which the approval was based, spoke with i3 Health about the approval's significance, notable adverse events with lurbinectedin, and the wealth...

In Cancer Patients With DVT, IVC Filter Reduces Pulmonary Embolism Risk

A new study finds that for patients with cancer and deep vein thrombosis (DVT), placement of an inferior vena cava (IVC) filter reduces the risk of pulmonary embolism. Venous thromboembolism (VTE) poses a substantial problem for patients with cancer: it occurs four to seven times more frequently in this population, and it is the second overall leading cause of death for patients with known malignancies. Pulmonary embolism is a potentially deadly condition that can develop as a result of VTE, and...

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