VALCHLOR® (mechlorethamine) gel is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF‑CTCL) in patients who have received prior skin-directed therapy

Proven efficacy in treating patients with Stage IA and IB MF-CTCL, as shown in a 12-month study1

Percentages of patients with confirmed Composite Assessment of Index Lesion Severity (CAILS) response1

chart showing complete and partial patient CAILS response to treatment

A CAILS score is obtained by adding the severity score of each of the following categories for 5 index lesions: erythema, scaling, plaque elevation, and surface area. A response was defined as a ≥50% reduction from baseline CAILS score, which was confirmed at the next visit at least 4 weeks later. A complete response was defined as a confirmed CAILS score of 0 (none).

Comparable CAILS response to compounded nitrogen mustard1

  • 60% of VALCHLOR patients (n=119) had an overall response compared with 48% of patients treated with compounded mechlorethamine HCl 0.02% ointment (n=123)
  • VALCHLOR was comparable (non-inferior) to compounded mechlorethamine 0.02% based on a CAILS overall response rate ratio of 1.24 (95% confidence interval, 0.98 to 1.58)

CAILS overall response for both treatment arms showed a wide range from 1 to 11 months1

Percentages of patients with confirmed Severity Weighted Assessment Tool (SWAT) response1

chart showing complete and partial patient SWAT response to treatment

The SWAT score is derived by measuring each involved area as a percentage of total body surface area (% BSA) and multiplying it by a severity weighting factor (1=patch, 2=plaque, 3=tumor or ulcer). A response was defined as a ≥50% reduction from baseline in SWAT score, which was confirmed at the next visit at least 4 weeks later.

Comparable SWAT response to compounded nitrogen mustard1

  • 50% of VALCHLOR patients (n=119) had an overall response compared with 46% of patients treated with compounded mechlorethamine HCl 0.02% ointment (n=123)

Study design: The efficacy of VALCHLOR was assessed in a randomized, multicenter, observer-blind, non-inferiority trial of 260 patients. Patients were stratified based on Stage (IA vs IB and IIA) and then randomized to receive VALCHLOR gel 0.016% w/w of mechlorethamine (equivalent to 0.02% mechlorethamine HCl) or Aquaphor®-based mechlorethamine HCl 0.02% ointment (compounded mechlorethamine). Patients had received at least one prior skin-directed therapy. Qualifying prior therapies included topical corticosteroids, phototherapy, Targretin® gel, and topical nitrogen mustard. Patients were not required to be refractory to or intolerant of prior therapies. Treatments were applied topically on a daily basis for 12 months. Please note that while Stage IIA patients were included in the trial population, VALCHLOR is only indicated for Stage IA and IB MF‑CTCL.1

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VALCHLOR is contraindicated in patients with known severe hypersensitivity to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine.

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The most common adverse reactions (≥5%) were dermatitis (56%), pruritus (20%), bacterial skin infection (11%), skin ulceration or blistering (6%), and hyperpigmentation (5%). These reactions may be moderately severe or severe. Elderly patients aged 65 and older may be more susceptible. Depending on severity, treatment reduction, suspension, or discontinuation may be required.

DOSING AND APPLICATION

VALCHLOR is for topical dermatologic use only. Apply a thin film of gel once daily to affected areas of the skin. VALCHLOR is a cytotoxic drug and special handling and disposal procedures should be followed during use. Caregivers must wear disposable nitrile gloves when applying VALCHLOR. Patients and caregivers must wash hands thoroughly after handling or applying VALCHLOR.

To report SUSPECTED ADVERSE REACTIONS, contact Helsinn Therapeutics (U.S.), Inc., at 1-855-4-VALCHLOR (1-855-482-5245) or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see VALCHLOR full Prescribing Information.