News Briefs & FDA Updates

OBTNDecember 2009
Volume 0

Capsule summaries of current issues and developments in breast cancer, kidney disease, supportive care, and melanoma are presented, as well as timely updates on FDA actions and approvals.

Click here to view PDF.IN THE NEWSBriefsBREAST CANCER Paclitaxel Ups Risk of Neuropathic Pain

Journal of Pain

A study at the University of Texas M.D. Anderson Cancer Center has found that paclitaxel may significantly increase the risk of neuropathic pain in breast cancer survivors. Of 240 breast cancer patients surveyed who participated in clinical trials of paclitaxel between 1994 and 2001, 64% experienced neuropathic pain during treatment, while 27% were diagnosed post-treatment with chronic neuropathic pain. Researchers concluded that neuropathic pain at the time of chemotherapy could indicate a risk for chronic neuropathic pain and these patients should be regularly monitored after treatment. The study is published in the November issue of .

Soy: Friend or Foe?

Many breast cancer survivors avoid eating soy because studies suggested it might induce estrogen-like activity. A study of 5000 Chinese breast cancer survivors published in the Journal of the American Medical Association says women should eat more soy, not less. The women were tracked for 4 years and those who ate the most soy had the lowest rates of recurrence and death regardless of whether the primary tumor was estrogen-positive or estrogen-negative.

KIDNEY DISEASE FDA Debates Restricting MRI Drugs

A panel formed to advise the FDA is deciding whether all or some of the 7 gadolinium-containing contrast dyes approved to enhance MRI images should be restricted to individuals without severe kidney problems. Among the drugs being debated are General Electric Co’s Omniscan, Bayer’s Magnevist, and Covidien Limited’s Optimark. The FDA has said that these products put patients with severe kidney disease at increased risk for the potentially fatal skin condition known as nephrogenic systemic fibrosis. The FDA updated labeling for these drugs in 2006 to warn against their use in these patients but use was still allowed at the physician’s discretion. Gadodiamide and gadoversetamide are considered two of the dyes with the highest risk for patients with impaired renal function.

Cancerous Kidneys Treated

The University of Maryland’s School of Medicine transplanted donor kidneys from patients with kidney cancer into 5 individuals with end-stage renal failure. All these patients were at death’s door, waiting for a healthy donor. The surgeons removed all traces of the tumors from the cancer-riddled kidneys prior to surgery, and after 9 to 41 months, none of the renal patients has developed cancer. One died from an unrelated accident. Michael Phelan, who co-authored the study said, “The global increase in patients with end-stage renal disease” meant looking at other ways to increase the donor pool.


FDA Requests Plan from Opioid Manufacturers

Sixteen pharmaceutical companies that manufacture a cumulative 24 painkillers—including optimorphine, oxycodone, and methadone—collaborated on a joint risk-management plan for preventing opioid abuse, which they submitted to the FDA. The regulatory agency ordered the companies to develop a plan to help stem the tide of deaths from painkiller overdose. The manufacturers suggested providing medication guides for patients and additional training for physicians on the appropriate uses for opioids. According to a 2007 survey, 5.2 million Americans admitted using painkillers inappropriately. Patients’ rights groups are worried that making requirements burdensome on physicians may inhibit them from prescribing the drugs to patients who genuinely need them.


Are Kangaroos Skin Cancer Proof?

Researchers at the University of Melbourne, Australia, and the University of Innsbruck, Austria, are studying kangaroos’ response to ultraviolet light exposure in the laboratory to figure out why kangaroos do not get melanoma. They have found that kangaroos produce an enzyme that repairs DNA damage after sun exposure. Other animals also produce similar enzymes, but humans do not. The researchers said they’ve discovered a number of new chemicals in their studies and hope to someday be able to replicate these.

FDA Updates

Abraxis has been granted orphan drug status by the FDA for Abraxane (Nab-paclitaxel) in stage IIB-IV melanoma. Abraxane is already approved for breast cancer and was granted orphan drug status in September for pancreatic cancer. Abraxis plans to test Abraxane in a phase III study versus dacarbazine in patients with chemotherapy-naïve advanced melanoma.

Istodax (romidespin) has been approved by the FDA to treat cutaneous T-cell lymphoma. Istodax is a new injectable medication, and 35% of patients in two clinical studies demonstrated tumor responses lasting a median of 11 to 15 months. In addition, 6% had complete response.

Cequent’s investigational new drug application for CEQ508 has been approved, allowing the company to move forward with trials of the drug in patients with familial adenomatous polyposis. This trial will be the first ever for an orally administered RNA interference drug in humans. Based on proprietary tkRNAi technology, CEQ508 targets beta-catenin, a key oncogene in colonic polyp formation and the progression of polyps to colorectal cancer.

Fast-track approval has been granted to KRX-0401, also known as Perifosine. The drug is in phase II mid-stage clinical development for multiple tumor types; investigators are preparing to commence a phase III late-stage trial for multiple myeloma. Earlier this year, the FDA gave Perifosine orphan drug designation. AEterna Zentaris of Quebec, Canada, and Keryx Biopharmaceuticals Inc of New York are partnering on the drug in North America.

The Cardiovascular and Renal Drugs Advisory Committee recommended 11 to 1 that the FDA approve Novartis’ Afinitor (everolimus) to prevent organ rejection in patients who have undergone kidney transplants. An advisory panel suggested that the company adopt a risk-management plan to minimize the drug’s potential side effects.

Israel’s generic biopharmaceutical company Teva is seeking FDA approval of a Biologics License Application for XMO2 (marketed in Europe under the name TevaGrastim) for the treatment of chemotherapyinduced neutropenia. The drug is a biosimilar of Amgen’s Neupogen (filgrastim). The FDA does not currently have an established pathway for securing regulatory approval of a biosimilar drug, and Amgen may legally oppose the filing.

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