Lugano, Switzerland, March 18, 2021 – Helsinn, a Swiss pharmaceutical group focused on
building quality cancer care and rare disease products, is pleased to note the publication of results
from the PROVe study, providing two year real world data for mechlorethamine gel 0.016% topical
use in combination with other therapies, for early stage MF-CTCL.
Mechlorethamine gel 0.016%, also known as chlormethine gel, is approved for use in multiple
countries including the US and EU and is marketed under the trade names VALCHLOR® and
LEDAGA®. The authorized use for each country varies based on the individual health authority
requirements. For more details, please refer to the product information for the respective countries:
VALCHLOR® USPI, and LEDAGA® SmPC.
The PROVe study is, to date, the largest open label, single arm, multicenter observational study
assessing treatment patterns and efficacy, safety, and health-related quality of life (HRQOL)
outcomes in early stage MF-CTCL patients treated with mechlorethamine gel and other therapies
in a real-world setting in the US. 298 patients were monitored for up to two years during standardof-care clinic visits.
Results from the PROVe study, published in the American Journal of Clinical Dermatology, provide
additional data that mechlorethamine gel is commonly used in the US clinical practice with other
therapies, the most commonly co-administered therapies were corticosteroids, phototherapy, and
oral bexarotene. This information provides healthcare professionals flexibility in their approach to
treating MF-CTCL with a variety of other skin directed therapies in addition to mechlorethamine
gel. It was noted that the topical gel can be applied by the patient or caregiver in the privacy of
their own home, offering patients convenient access to a useful therapeutic option. HRQOL data
was also collected from patients, providing information based on three subscales: emotions,
symptoms and functioning.
Link to publication: The PROVe Study: US Real-World Experience with
Chlormethine/Mechlorethamine Gel in Combination with Other Therapies for Patients with Mycosis
2
Fungoides Cutaneous T-Cell Lymphoma - https://link.springer.com/article/10.1007/s40257-021-
00591-x
This latest research builds on a growing body of evidence from Helsinn on the use of
mechlorethamine gel, with publications recently featured in the journal of Clinical Lymphoma
Myeloma and Leukemia and the Journal of Investigative Dermatology.
Ellen J. Kim, M.D. Lead Author, Principal Investigator and Professor of Dermatology at the
Hospital of the University of Pennsylvania: “I’m pleased that we are able to publish this
important study, the largest of its kind in MF-CTCL patients. It clearly demonstrates the
effectiveness of this topical gel, particularly when administered over a sustained period.”
William L. Bailey, Helsinn Therapeutics (U.S.) Vice President of Medical & Scientific Affairs,
commented: “This valuable study builds on other recent research on the use of mechlorethamine
treatment in MF-CTCL patients. These findings underline VALCHLOR®’s suitability for home use,
making it an attractive treatment option for both patients and clinicians, as they seek to find
treatment options outside the clinical setting.”