FDA Oncology Approvals: Limitations In Clinical Trial Design

Fully two-thirds of anticancer drug clinical trials leading to FDA approvals over the course of a five-year period from 2014 to 2019 had at least one important limitation that could potentially impact the utility of the results, report the authors of an observational study published today in JAMA Internal Medicine. "Clinical trials leading to marketing authorization of anticancer drugs by the US Food and Drug Administration (FDA) are heterogeneous, with varying strengths and weaknesses," write t...
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Febrile Neutropenia: FDA Approves Pegfilgrastim Biosimilar

The FDA has now approved pegfilgrastim-apgf (NyvepriaTM, Pfizer), a biosimilar of pegfilgrastim (Neulasta®, Amgen), for the prevention of febrile neutropenia in patients receiving myelosuppressive treatment for non-myeloid cancers. For patients with non-myeloid malignancies, chemotherapy and other anti-cancer medicines can often result in neutropenia, a condition involving an abnormally low number of neutrophils––a type of white blood cell––which increases the chance of life-threatening infectio...
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Metronomic Capecitabine Maintenance for TNBC: Zhongyu Yuan, MD

Metronomic capecitabine maintenance therapy has been shown to be more effective compared with observation for patients with triple-negative breast cancer (TNBC), according to a study led by Zhongyu Yuan, MD. Results of the study have been presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. In this interview with i3 Health, Dr. Yuan shares insights on treating TNBC and future directions in the TNBC treatment landscape. What are the most challenging aspec...
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Nivolumab FDA Approved for Esophageal Squamous Cell Carcinoma

Nivolumab (Opdivo®, Bristol Myers Squibb) is now FDA approved for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior fluoropyrimidine- and platinum-based chemotherapy. Previously approved for metastatic non-small cell lung cancer, melanoma, and advanced renal cell carcinoma, among others, nivolumab is an immunotherapy that works by helping immune cells discover and attack cancer cells by inhibiting a cancer cell's abili...
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FDA Approves Nivolumab/Ipilimumab/Platinum-Doublet Chemotherapy: NSCLC

Nivolumab (Opdivo®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb) in combination with 2 cycles of platinum-doublet chemotherapy has been FDA approved for treatment-naive patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Approval was based on the randomized, open-label trial CHECKMATE-9LA (NCT03215706). A total of 719 patients with met...
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