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Listing ID: 191
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Drug Product Name: VALCHLOR Rx

Pharmacological Class:
Nitrogen mustard.

Active Ingredient(s):
Mechlorethamine 0.016%; topical gel; contains propylene glycol, isopropyl alcohol.

Actelion Pharmaceuticals

Treatment of Stage IA and IB mycosis fungoides-type ­cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
Mechlorethamine, also known as nitrogen mustard, is an alkylating agent which inhibits rapidly proliferating cells.
Clinical Trials:
The efficacy of Valchlor was assessed in a randomized, multicenter, observer-blind, active-controlled, non-inferiority clinical trial involving 260 patients with Stage IA, IB, and IIA mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) who had received ≥1 prior skin-directed therapy (eg, topical corticosteroids, phototherapy, Targretin gel, or topical nitrogen mustard). Patients were not required to be refractory to or intolerant of prior therapies.
Patients were randomized (after stratification based on Stage IA vs. IB and IIA) to receive Valchlor (N=119) or Aquaphor-based ointment (N=123), both equivalent to 0.02% mechlorethamine. The study drug was to be topically applied once daily for 12 months, and concomitant use of topical corticosteroids was not permitted.
Patients were evaluated monthly for the first 6 months, then every 2 months for the last 6 months using the Composite Assessment of Index Lesion Severity (CAILS) score. A response was defined as ≥50% reduction in baseline CAILS score, which was confirmed at the next visit ≥4 weeks later; a complete response was defined as a confirmed CAILS score of 0.
Patients were also evaluated using the Severity Weighted Assessment Tool (SWAT). A response was defined as ≥50% reduction in baseline SWAT score, which was confirmed at the next visit ≥4 weeks later.
At 12 months, 60% of patients treated with Valchlor and 48% of patients treated with the comparator achieved a response based on CAILS score. Valchlor was non-inferior to the comparator based on a CAILS overall response ratio of 1.24 (95% CI 0.98, 1.58). Complete responses constituted a minority of the CAILS or SWAT overall responses. The onset of CAILS overall response for both treatment arms showed a wide range from 1 to 11 months.
Legal Classification:
Apply a thin film once daily to affected areas of the skin. Apply to completely dry skin ≥4 hours before or 30 minutes after showering or washing. Allow treated areas to completely dry for 5–10 minutes after applying. Wash hands thoroughly after application. Discontinue if any grade of skin ulceration, blistering, or moderately-to-severe, or severe dermatitis occur; restart at reduced frequency of once every 3 days upon improvement; if reintroduction is tolerated for at least 1 week, can increase to every other day for 1 week and then once daily if tolerated.
Not established.
Mucosal (oral, nasal) or eye exposure; blindness and severe irreversible anterior eye injury may occur; immediately irrigate for ≥15 minutes with copious amounts of water. Secondary exposure; avoid direct skin contact with patient. Risk of dermatitis (eg, face, genitalia, anus, and intertriginous skin); monitor for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections. Monitor for nonmelanoma skin cancer during and after treatment. Flammable (avoid fire and flame until gel has dried). Pregnancy (Category D); may cause fetal harm. Nursing mothers: not recommended.
Adverse Reaction(s)
Dermatitis, pruritus, bacterial skin infection, skin ulceration or blistering, hyperpigmentation.
How Supplied:
Price: No price
Listing ID: 191

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