Newly Approved Cancer Treatments

by National Cancer Institute

Introduction

Included here are brief descriptions of cancer therapies that the U.S. Food and Drug Administration (FDA) has approved within the last three years.

The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.

Sometimes the therapies listed here will be brand new. Other times, therapies already approved for one use will have received FDA approval for specific, newly documented uses ("indications") in the treatment of cancer.

The summaries are provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products, and Patricia Keegan, M.D., director of the FDA's Division of Clinical Trials Design and Analysis. Each summary includes a link to the complete product label, which provides clinical information on the indication, contraindications, dosing and safety of the product.

For further information related to oncology drug approvals, regulatory information and other oncology resources, please refer to the FDA's Oncology Tools Web site.

Abraxane

On January 7, 2005, the FDA approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (Abraxane™, a trademark of American BioScience, Inc.) for treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

The clinical database included two single arm studies enrolling a total of 106 patients and one multicenter randomized trial. The multicenter trial was conducted in 460 patients with metastatic breast cancer who were randomized to receive either Abraxane 260 mg/m2 administered as a 30-minute infusion or paclitaxel 175 mg/m2 given over three hours.

Fifty-nine percent of patients had received one or more prior chemotherapy regimens, and 77 percent had received an anthracycline-containing regimen. The objective response rate verified by central review was 21.5 percent (95 percent CI: 16.2 percent to 26.7 percent) for Abraxane compared to 11.1 percent (95 percent CI: 6.9 percent to 15.1 percent) for paclitaxel (p=0.003).

Clinically important adverse events (all grade) in the randomized trial comparing Abraxane to paclitaxel included neutropenia (80 percent with Abraxane and 82 percent with paclitaxel), anemia (33 percent vs. 25 percent), infections (24 percent vs. 20 percent), hypersensitivity reactions (4 percent vs. 12 percent), sensory neuropathy (71 percent vs. 56 percent), edema (10 percent vs. 8 percent), nausea (30 percent vs. 21 percent), vomiting (18 percent vs. 9 percent), diarrhea (26 percent vs. 15 percent), and mucositis (7 percent in both arms).

Severe adverse events (grade 3 or 4) included neutropenia (9 percent with Abraxane and 22 percent with paclitaxel), myalgia/arthralgia (8 percent vs. 4 percent) and vomiting (4 percent vs. 1 percent). Ten percent (24 patients) treated with Abraxane developed grade 3 peripheral neuropathy; 14 of these patients showed some improvement of neuropathy at a median of 22 days. Two percent of patients receiving paclitaxel developed grade 3 peripheral neuropathy.

The recommended dose of Abraxane is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks. No premedication to prevent hypersensitivity reactions is required prior to Abraxane administration.

Aldara

On July 15, 2004, the FDA announced the approval of a new indication for Aldara® (imiquimod) topical cream. This product is currently approved for the treatment of actinic keratosis and external genital warts. The FDA has now approved its use for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

This type of skin cancer is diagnosed by a healthcare provider after biopsy and is different from other types of skin cancer including other types of basal cell carcinoma.

Superficial basal cell carcinoma is usually treated by surgical removal. Aldara should be used for treatment of sBCC only when surgery is medically less appropriate, because the chances of effectively treating sBCC are generally greater with surgery. Patients treated with Aldara for sBCC should have regular follow-up visits after treatment to make sure the skin cancer is completely treated.

The safety and effectiveness of Aldara were established in two double-blind controlled studies with approximately 364 patients. In these studies, 75 percent of patients (139/185) who had their sBCC treated with Aldara had no evidence clinically or on repeat biopsy of their sBCC at 12 weeks after finishing treatment. In a separate long-term study involving 182 patients, 79 percent of patients had no evidence of their sBCC at two years after finishing treatment.

Skin cancer can occur anywhere on the body, but it is most common on skin that has been exposed to sunlight. The most common type of skin cancer is basal cell carcinoma, affecting at least 800,000 Americans each year. The superficial type of basal cell carcinoma usually occurs on the arms, legs or on parts of the body such as the chest or back. Now FDA is approving Aldara for treatment of sBCC on the body, neck, arms or legs, but not for treatment of sBCC on the face.

Most patients using Aldara Cream for the treatment of sBCC experienced skin reactions at the treatment site, which include redness, swelling, a sore or blister, peeling, itching, and burning.

Aldara Cream is manufactured by 3M Pharmaceuticals of St. Paul , Minn.

About the Author

www.nci.nih.gov
The National Cancer Institute's research programs are extensive and contain many innovative initiatives. I invite you to explore our Web site to find out more about the exciting work being conducted here at NCI and by NCI-supported scientists throughout the country.