Paxman is seeking approval for using its scalp cooling device as an intervention to prevent chemotherapy-induced alopecia (CIA) in women undergoing chemotherapy treatment for breast cancer.
A medical device company in the United Kingdom, Paxman, has announced the submission of clinical evidence for its Paxman Scalp Cooling System, for regulatory clearance by the FDA. The company is seeking approval for using the device as an intervention to prevent chemotherapy-induced alopecia in women undergoing specific chemotherapy treatment for breast cancer.
The company, a pioneer in the field of scalp cooling, has over 2 decades of global experience. According to the company website, clinical trials that incorporated Paxman as a preventive intervention were quite effective—43% to 93.7%—in preventing hair loss following chemotherapy. In the United States, Paxman has partnered with Baylor Breast Cancer Center for a phase 3 trial to measure success in hair preservation (CTCAE v 4 alopecia grade less than 2) as the primary outcome. The secondary outcomes measure of the trial, with a time frame of 4 to 8 months, is improved quality of life, to be measured every 2 to 3 weeks after every course of chemotherapy.
Initiated in December 2013, the study is expected to be completed by December 2018. Newly diagnosed patients with stage 1 or 2 breast cancer, undergoing anthracycline- or taxane-based chemotherapy regimens, are eligible to participate in the trial. The company has also partnered with other cancer treatment centers within the United States, including Cleveland Clinic, Memorial-Sloan Kettering Cancer Center, Carol G. Smith Cancer Center in Morristown, NJ, and several US Oncology sites, according to a company press release. And it is data from these studies that was presented at the recently concluded San Antonio Breast Cancer Symposium and also submitted to the FDA.
The release states that 50.5% of women in the scalp cooling group had hair preservation, compared with 0% in the control no cooling group. This led the researchers, led by Julie Nangia, MD, assistant professor of medicine at Baylor College of Medicine, Houston, to stop the trial early.
If approved, Paxman will be just the second scalp cooling device to be cleared for marketing by the FDA. Digitana Inc’s DigniCap was cleared in December 2015.
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen
Lack of Mutations Associated With Favorable Prognosis in MPN-U
April 25th 2024While the Dynamic International Prognostic Scoring System and bone marrow blasts may predict overall survival, the lack of certain mutations is also associated with a better prognosis for myeloproliferative neoplasm, unclassifiable (MPN-U).
Read More
What We’re Reading: FDA Approves UTI Antibiotic; Ozempic, Wegovy Price Investigation; US Births Fall
April 25th 2024The FDA recently approved an antibiotic for the treatment of urinary tract infections (UTIs) in women; a Senate committee recently launched an investigation into the prices of Novo Nordisk’s diabetes and weight loss drugs; US births fell last year, resuming a national slide after a previous increase during the pandemic.
Read More