© 2022 MJH Life Sciences™ and CURE - Oncology & Cancer News for Patients & Caregivers. All rights reserved.
The FDA based its decision on data from a phase 3 trial which showed that adding plinabulin to Neulasta significantly improved the rate of severe chemotherapy-induced neutropenia.
The Food and Drug Administration (FDA) has granted plinabulin a breakthrough therapy designation for the treatment of chemotherapy-induced neutropenia, a blood count problem, according to BeyondSpring, the agent’s manufacturer.
“Receipt of breakthrough therapy designation from the FDA acknowledges both the significant unmet need among patients with (chemotherapy-induced neutropenia) and the highly encouraging clinical results generated by plinabulin,” said Dr. Douglas Blayney, global principal investigator of plinabulin’s chemotherapy-induced neutropenia studies, in a company-issued press release.
The designation is based on plinabulin’s reported activity in patients with neutropenia, including positive results from the phase 3 PROTECTIVE-2 study. The study showed that the addition of plinabulin to the current standard of care, Neulasta (pegfilgrastim), significantly improved the rate of severe chemotherapy-induced neutropenia.
Results from the PROTECTIVE-2 study also indicated that the combination of plinabulin and Neulasta demonstrated a better safety profile and fewer severe side effects than Neulasta alone.
“This should expedite plinabulin’s move into the clinic, which is beneficial for patients,” Blayney, who is a professor of medicine at Stanford Medical School, said in the release. “The currently approved (chemotherapy-induced neutropenia) prevention agents are all G-CSF (granulocyte colony stimulating factor)-based and not available to all patients. Even with the use of G-CSFs, over 80% of cancer patients undergoing chemotherapy may still experience grade 4 neutropenia, which could lead to severe infection, hospitalization and even death. Thus, (chemotherapy-induced neutropenia) still represents an unmet medical need.”
A breakthrough designation means the therapy will have an expedited regulatory review and development. BeyondSpring expects to report complete data from the PROTECTIVE-2 trial at some point during the last several months of 2020. The company also expects to file a new drug application with the FDA by the end of 2020.
FDA Grants Orphan Drug Designation to Novel CAR-T Cell Therapy to Treat Waldenstrom Macroglobulinemia, a Rare Type of Cancer
New Resource ‘Empowers’ Patients With Breast Cancer That Has Spread to the Brain With Much Needed Information
Cancer Boosted My Empathy, But Anger Is Starting to Rear Its Head
FDA Approves Breyanzi for Previously Treated Large B-Cell Lymphoma