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...
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Pyrotinib/Capecitabine Effective for HER2-Positive Metastatic Breast Cancer

Pyrotinib, an irreversible pan-ErbB inhibitor, provides an effective treatment option in combination with capecitabine for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer, according to results of a phase 3 trial to be presented later this month in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. The open-label, multicenter PHOEBE trial enrolled patients with HER2-positive metastatic breast cancer following treatment...
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Progress in Metastatic Castration-Sensitive Prostate Cancer: Andrew J. Armstrong, MD, MSc

Last week, Andrew J. Armstrong, MD, MSc, lead researcher of the phase 3 ARCHES trial, spoke with i3 Health about the recent approval of enzalutamide (Xtandi®, Astellas Pharma Inc.) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) and the variety of options that are now available for the treatment of metastatic hormone-sensitive disease. In this second installment, Dr. Armstrong discusses the ongoing evolution of therapeutic strategies in mCSPC and shares his advice fo...
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Olaparib Approval: BRCA-Mutated Metastatic Pancreatic Cancer

The FDA has now approved olaparib (Lynparza®, AstraZeneca) for the maintenance treatment of adults with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma who have not experienced disease progression after at least 16 weeks of a first-line platinum-based chemotherapy regimen. In addition, the FDA approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) as a companion diagnostic for the selection of patients with deleterious or suspected ...
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Enzalutamide Approval: Metastatic Castration-Sensitive Prostate Cancer

The FDA has now approved enzalutamide (Xtandi®, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Patients with mCSPC, who comprise up to 5% of US patients with prostate cancer, have metastatic disease and either have not yet received or are continuing to respond to hormone therapy. Androgen deprivation therapy (ADT) has been considered the standard of care for mCSPC. After experiencing an initial treatment response, most patients who receive ADT al...
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