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Clinical Notes

doi: 10.1097/01.COT.0000345501.80654.09
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FDA Approval for Microwave Ablation for Nonresectable Liver Cancer

The FDA has approved the use of the Evident Microwave Ablation System, for nonresectable liver tumors, offering an option for patients who are not candidates for surgical resection and making possible percutaneous, laparoscopic, or open surgical soft-tissue ablation.

Information from the manufacturer, Covidien, notes that the Evident system allows ablations to be achieved in approximately 10 minutes, which is about 60% faster than with other ablation products, meaning that less time is spent in the operating or radiology rooms for both patients and medical professionals as well as less time under anesthesia for patients.

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Degarelix Approved for Advanced Prostate Cancer

The FDA has approved the use of the injectable drug degarelix for the treatment of advanced prostate cancer, making it the first new drug in several years for prostate cancer.

Degarelix is a gonadotropin-releasing hormone receptor (GnRH) inhibitor, which slows the growth and progression of prostate cancer by suppressing testosterone.

A news release from the FDA notes that hormonal treatments for prostate cancer may cause an initial surge in testosterone production before lowering testosterone levels. This initial stimulation of the hormone receptors may temporarily prompt tumor growth rather than inhibiting it, but degarelix doesn't do this.

“Prostate cancer is the second leading cause of cancer death among men in the United States and there is an ongoing need for additional treatment options for these patients,” said Richard Pazdur, MD, Director of the FDA's Office of Oncology Drug Products.

The drug's efficacy was established in a clinical trial in which patients with prostate cancer received either degarelix or leuprolide, and the results showed that degarelix did not cause the temporary increase in testosterone that is seen with some other drugs that affect GnRH receptors. Nearly all of the patients on either drug had suppression of testosterone to levels seen with surgical removal of the testes.

The most frequently reported adverse reactions were injection site reactions (pain, redness, and swelling), hot flashes, increased weight, fatigue, and increases in some liver enzymes.

Degarelix is manufactured by Ferring Pharmaceuticals of Parsippany, NJ, and Rentschler Biotechnologie Gmbh of Laupheim, Germany.

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FDA Approval for Mozobil as Stem Cell Booster in Bone Marrow Transplant Patients

The FDA has approved the use of Mozobil (plerixafor) to be used in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma. The drug also has Orphan Drug status.

In the randomized clinical trial of NHL used for the NHL approval, 59% of patients who received plerixafor and G-CSF collected the target number of at least 5 million stems cells/kg of body weight in four or fewer apheresis sessions compared with only 20% of placebo patients. The median number of days to reach the target cell count was three days for the plerixafor group and not evaluable in the placebo group.

And in the myeloma trial used for the approval, 72% of patients who received plerixafor and G-CSF collected the target number of at least 6 million stem cells/kg of body weight in two or fewer apheresis sessions compared with 34% of placebo patients. The median number of days to reach the target cell count was one day for the plerixafor group and four days for the placebo group.

Updated 12-month follow-up findings showed that graft durability rates for patients in the plerixafor-plus-GCSF and placebo-plus-GCSF groups were comparable.

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Orphan Drug Status for Two Melanoma Drugs

Two drugs have received Orphan Drug Status for melanoma: Tesetaxel, made by Genta, for advanced melanoma; and 131I-TM601, made by TransMolecular, for Stages IIb to IV melanoma.

Tesetaxel, a new, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel, was developed to maintain the high antitumor activity of the taxane drug class while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral option also enables the development of new schedules that may expand dosing options when tesetaxel is used alone or in combination with other anticancer drugs.

Information from Genta notes that some 250 patients worldwide have been treated with tesetaxel in Phase I and II clinical trials; and that preclinically, tesetaxel has demonstrated substantially higher activity against cell lines that were resistant to paclitaxel and docetaxel, since acquired resistance is not mediated by the multidrug-resistant glycoprotein.

TransMolecular's radiolabeled 131I-TM601, which had previously received Orphan Drug Status for glioma, is a wholly synthetic peptide originally derived from scorpion venom, which is highly specific and selective in targeting both primary tumors and metastases in the periphery and the central nervous system.

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FDA Issues Guide on Use of Data When Subjects Withdraw from Clinical Trials

The FDA has issued a report clarifying its position requiring that data from clinical trial participants be retained if the person discontinues participation or is withdrawn from a study.

The guide, intended for sponsors, clinical investigators, and institutional review boards, notes that clinical studies data are submitted to the FDA in support of research applications for a new product approval, and that it is critical that the agency have a complete and accurate data set to make decisions. Incomplete data can compromise the scientific validity of investigations and jeopardize the FDA's ability to analyze the study and, eventually, to safeguard the public health.

The full report can be accessed online at under “Newly Added Guidance Documents.”

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FDA Approval for Gleevec to Prevent GIST Recurrence

The FDA has approved another indication for imatinib (Gleevec)—to prevent cancer recurrence following surgery for gastrointestinal stromal tumor (GIST).

“Approval of Gleevec offers health care professionals and patients an important new therapeutic option for patients with this uncommon gastrointestinal disease,” Richard Pazdur, MD, Director of the FDA's Office of Oncology Drug Products, said in a news release. “It illustrates how the continued study of a once novel drug throughout its product lifecycle can yield new and important uses.”

Gleevec is now approved for nine indications.

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Lung Cancer Risk Linked to SNPs of ABC Transporter Genes

Individuals with particular variants of certain genes involved in metabolizing the most potent carcinogen in cigarette smoke have an increased risk of developing lung cancer. That is the conclusion of a study in the February 1 issue of Cancer by a team of scientists led by Dr. Daru Lu and Dr. Haijian Wang of the Institute for Advanced Study at Fudan University in Shanghai.

The carcinogen, nitrosamine 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), is a component of cigarette smoke that has already been shown to cause lung cancer in rodents. A news release notes that certain enzymes act to protect the body from this type of chemical by turning it into nontoxic forms or by transporting it from cells. For example, ATP-binding cassette transporters encoded by the ABCB1 and ABCC1 genes are involved in eliminating carcinogens from the lungs, protecting them against inhaled toxins.

Researchers have theorized that people with alterations in these genes might have an increased susceptibility to develop lung cancer, and the same researchers had recently identified common variants at the beginning and end of the ABC1 and ABCC1 genes. The new study was an analysis of these variants in 500 patients with lung cancer and 517 cancer-free controls in a Chinese population.

Patients who had the variant allele of either ABCB1 rs3842 or ABCC1 rs212090 had a significantly increased risk of developing lung cancer; and the former was particularly associated with an increased risk of cancer in women, in people younger than 60, and of adenocarcinoma.

“Because tobacco smoking is the leading preventable cause of cancer and the cancer-prone genotypes of these genetic components are relatively prevalent in the human population, our findings have important implications for the prevention of tobacco smoking-related cancers,” the authors wrote.

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© 2009 Lippincott Williams & Wilkins, Inc.
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