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Oncology Times:
doi: 10.1097/01.COT.0000413018.23423.ce
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FDA Approvals for Supplemental NDA for Velcade for Myeloma and Mantle Cell Lymphoma, and Picato Gel for Actinic Keratosis

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The FDA has approved an update to the label for Velcade (bortezomib) to include the subcutaneous method of administration in its approved indications including multiple myeloma and mantle cell lymphoma after at least one prior therapy.

The approval comes after a randomized, Phase III, open-label, international trial including 222 myeloma patients published last spring in Lancet Oncology (2011;12:431-440) showed subcutaneous bortezomib to be as effective as standard intravenous administration, with an improved safety profile.

Patients receiving single-agent bortezomib subcutaneously achieved an overall response rate of 43% and a complete response rate of 7% after four cycles, while patients receiving the drug intravenously achieved an overall response rate of 42% and a complete response rate of 8% after four cycles.

Although both methods showed similar safety profiles, in the subcutaneous arm of the trial only 6% of patients experienced peripheral neuropathy of grade 3 or higher, compared with 16% in the IV group. In the subcutaneous group, 38% of patients experienced neuropathy of all grades, compared with 53% of patients in the IV group.

“Considering this new subcutaneous route of administration for Velcade is important for our patients, including those with poor vein access and those with preexisting peripheral neuropathy or who are at high risk of developing peripheral neuropathy,” Noopur Raje, MD, Director of the Center for Multiple Myeloma at Massachusetts General Hospital Cancer Center, said in a news release from the drug's manufacturer, Millennium Pharmaceuticals.

The drug is for intravenous or subcutaneous use only: The updated label also includes a contraindication for intrathecal administration, as fatal events have occurred with the inadvertent intrathecal administration of Velcade.

The drug was first approved for treatment of myeloma in 2003 (OT/8/25/03) and was approved for injection in 2008 (OT/8/25/08).

Also newly receiving FDA approval is Picato (ingenol mebutate) gel to treat actinic keratosis via a topical application—once daily for three consecutive days for use on the face and scalp, and once daily for two consecutive days for use on the trunk and extremities.

Although other topical treatments are approved for actinic keratosis, which are potentially precancerous, full dosage for these drugs is usually several weeks, and even sometimes several months.

“Since there is no way to predict which actinic keratosis will advance to skin cancer, early detection and treatment of lesions are critical,” one of the clinical trial investigators, Mark Lebwohl, MD, Professor and Chair of the Department of Dermatology at Mount Sinai Medical Center, said in a statement. “What makes this new solution particularly exciting is the two- or three-day course of treatment.”

In phase III clinical testing, more than 60% of actinic keratosis patients had a 75% or greater reduction of lesions on the face and scalp with the gel (versus 7-8% reduction with placebo), and more than 44% had the same reductions on the trunk and extremities (versus 7% with placebo). In the trials, more than 37% of patients had complete clearance of actinic keratosis on their face and scalp, and more than 28% had complete clearance on the trunk and extremities (versus 5% in both instances with placebo).

Existing topical treatments for the condition include imiquimod cream (OT/8/10/04), fluorouracil, and diclofenac sodium gel, which all take several weeks to work and may require follow-up in-office treatment. The goal of in-office treatment options is to destroy the lesions, and include cryotherapy, chemical peels, curettage, photodynamic therapy, and laser resurfacing, according to the American Academy of Dermatology.

Actinic keratosis is one of the most commonly diagnosed dermatologic conditions (behind only acne and dermatitis), and causes 65 percent of squamous cell carcinomas, according to the AAD.

© 2012 Lippincott Williams & Wilkins, Inc.

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