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FDA Grants Pedmark Priority Review for Prevention of Cisplatin-Induced Ototoxicity in Solid Tumors

August 7th 2020

By Kristi Rosa

The FDA has granted a priority review designation to a new drug application for a unique formulation of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in patients from 1 month to less than 18 years of age with localized, nonmetastatic, solid tumors.

Longer Follow-Up Data Confirms Cemiplimab’s Utility in CSCC, Though Challenges Remain

August 7th 2020

By Jessica Hergert

Anna C. Pavlick, DO, discusses the benefit of cemiplimab for patients with cutaneous squamous cell carcinoma (CSCC), the impact of these longer follow-up data, rare, but notable, toxicities that can arise with the agent, and ongoing research efforts aimed at increasing responses to immunotherapy in the CSCC space.

Interim REFLECT Analysis Reconfirms Efficacy, Safety of Rituximab Biosimilar in DLBCL

August 7th 2020

By Erica DiNapoli

Manfred Welslau, MD, discusses findings from the REFLECT interim analysis that reconfirmed the activity of the rituximab biosimilar SDZ-RTX, in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with diffuse large B-cell lymphoma.

Refining Risk-Adapted Therapy in ER+ Breast Cancer

August 7th 2020

By Caroline Seymour

Eleftherios (Terry) P. Mamounas, MD, MPH, FACS, discusses the risk of late recurrence in early breast cancer, current approaches to extended adjuvant endocrine therapy, and ongoing research evaluating assays aimed at capturing both the risk of late recurrence and benefit from extended endocrine therapy.

FDA Approves Guardant360 CDx Liquid Biopsy for Comprehensive Genomic Profiling Across All Solid Cancers

August 7th 2020

By Kristi Rosa

The FDA has approved Guardant360® CDx for comprehensive genomic profiling in patients with any solid malignant cancer.

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