FDA Grants Combo Regimen Priority Review for Prevention of Chemotherapy-Induced Neutropenia


The Food and Drug Administration’s priority review will focus on the combination of plinabulin plus granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

The Food and Drug Administration (FDA) has granted priority review to an application seeking approval for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, according to a news release from BeyondSpring, the manufacturer of plinabulin.

“Chemotherapy is a very important therapy regimen for (patients with) cancer, even more so with its approval in combination with checkpoint inhibitors,” said Lan Huang, co-founder, CEO and chairwoman of BeyondSpring, in the release. “With COVID-19, the (National Comprehensive Cancer Network) panel had updated the guidelines to potentially double the patient population included in (chemotherapy-induced neutropenia) prevention. If approved, plinabulin and G-CSF combination would be an important new and improved option to prevent CIN for approximately 467,500 (patients with) cancer in the U.S. annually.”

Of note, the FDA grants drugs priority review that, if approved, would provide significant improvements over the standard-of-care treatment option.

The filing for the indication of the prevention of chemotherapy-induced neutropenia was based on results of several studies that enrolled more than 1,200 patients, including the phase 3 PROTECTIVE-2 trial.

Results of the PROTECTIVE-2 trial demonstrated that patients who received plinabulin plus the current standard of care, Neulasta (pegfilgrastim), achieved a prevention rate of grade 4 neutropenia of 31.5% versus 13.6% in those who received Neulasta alone. Moreover, patients who received the combination were less likely (58.6%) to report grade 4 side effects than those who received Neulasta alone (80%).

The agency is expected to make its decisions on whether to approve the combination by November 2021.

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