FDA Rejects Promising New Drug That Prevents Low White Blood Cell Counts in Patients Receiving Chemotherapy

FDA Rejects Promising New Drug That Prevents Low White Blood Cell Counts in Patients Receiving Chemotherapy

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The FDA delivered a blow on Wednesday to the millions of cancer patients who face the prospect of declines in white blood cell counts during chemotherapy — a condition known as chemotherapy-induced neutropenia (CIN) — when it denied approval for a promising new agent that has been under Priority Review: Plinabulin. But the news is not all bad. The agency has asked the manufacturer to provide additional data to support its application, indicating that plinabulin might still play a part in future cancer care.Neutropenia increases the risk for infections; hospitalizations for major complications, including dangerously low blood pressure, renal and respiratory challenges, and heart failure; as well as in-hospital death. Data published in May 2018 in the Journal of Clinical Oncology suggested that over 100,000 cancer patients receiving chemotherapy are…
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