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All Oncology News

Jorge J. Nieva, MD

If the FDA’s Oncologic Drugs Advisory Committee meeting held on February 10, 2022, was any indication, the days of applying foreign single country or region data to support regulatory approval are gone; instead, regulatory decisions are headed toward the need for regional consistency through multiregional clinical trials, which could help the United States overcome the persistent underrepresentation of racial and ethnic minorities in drug development.

Kevin Kalinsky, MD, MS

For Kevin Kalinsky, MD, MS, director of breast medical oncology at the Winship Cancer Institute of Emory University in Atlanta, Georgia, his work on the RxPONDER trial serves as one of a few accomplishments for which he is grateful that have impacted clinical care.

In recommendations released January 27, 2023, the National Comprehensive Cancer Network now advises physicians to consider neratinib for patients with HER2-negative metastatic breast cancer, regardless of estrogen receptor status, with activating mutations in the HER2 gene as detected by next-generation sequencing of tumor tissue or circulating tumor DNA.