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FDA Expands Indication for Scalp Cooling System to Include All Solid Tumors

Jason Harris
Published: Tuesday, Jun 12, 2018

The FDA has expanded the indication for the Orbis Paxman Hair Loss Cooling System to prevent chemotherapy-related alopecia in patients with solid tumors, device maker Paxman has announced. The system was approved last year to treat chemotherapy-related alopecia in patients with breast cancer.

In the cooling arm, 44.6% of patients used a wig or scarf compared with 68.5% in the control group. Among patients with grade 2 (>50%) hair loss, wig or scarf use was unknown for 20% of patients in the experimental arm versus 31.5% of the control group. No woman in the control group was known to go without a scarf or wig compared with 33.9% of the cooling group.


“This is another step forward in making cancer therapy more personalized and putting the patients in the driver’s seat as we create more options and pathways our patients,” Debu Tripathy, MD, professor and chair of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center, said in a statement.

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