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Accelerated Approvals in Oncology: Benefits, Risks, and the Way Forward With Dr. Jason Mouabbi, Dr. Ross Maclean, and Michael Glover

Oncology Data Advisor® · Accelerated Approvals in Oncology: Benefits, Risks, and the Way Forward In this interview, Dr. Jason Mouabbi, OncData Editorial Board Member and Breast Medical Oncologist at MD Anderson Cancer Center, speaks with Dr. Ross Maclean and Michael Glover about the debate surrounding accelerated FDA approvals, including their benefits, risks, and ways that physicians, patients, pharmaceutical companies, and the FDA can collaborate to maximize the impact of accelerate...

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Sacituzumab Govitecan-hziy Approved for HR-Positive Breast Cancer

The FDA has granted approval to sacituzumab govitecan-hziy (Trodelvy®, Gilead Sciences, Inc.) for treatment of unresectable, locally advanced, or metastatic hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer. Patients are required to have received at least one prior line of endocrine therapy and two systemic therapies in the metastatic setting. "Sacituzumab govitecan is a first-in-class trophoblast cell-surface antigen 2 (Trop-2)–directed antib...

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FDA Oncology Approvals in 2022: Timeline of Novel Treatment Options

The past year has been filled with new and exciting improvements and novel treatment options in the field of oncology and hematology. The FDA has granted approval and accelerated approval to many new drugs and drug combinations, including the very first approval for patients with HER2-mutant non–small cell lung cancer, trastuzumab deruxtecan. This is a great time to reflect on the current treatment landscape and ponder what 2023 could have in store for future approvals and emerging treatment opt...

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