Steven J. Isakoff, MD, PhD
An expanded indication for the Paxman Scalp Cooling System to include the prevention of chemotherapy-related alopecia in patients with solid tumors will increase the population eligible for the therapy dramatically and allow for more personalized treatment options, according to industry and academic experts.
The Paxman system, initially approved in April 2017, is the second scalp cooling system granted FDA approval for broad solid tumor indications. The agency approved the DigniCap System for patients with breast cancer in December 2015 and expanded that indication to include all solid tumors in July 2017.
Clinical Trial Data
The original breast cancer approval for the Paxman system was based on results from the SCALP trial (NCT01986140) first presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in JAMA
The investigators assessed hair preservation in 95 women assigned to scalp cooling versus a control group of 47 women who did not receive cooling.
... to read the full story