Archive for the 'Oncology products' Category

Pharmion wins positive opinion for thalidomide sale in Europe

European regulators have recommended the approval of thalidomide being reintroduced in the market for treating patients with a rare bone marrow cancer. Pharmion Corp. has Pharmion Logothe rights to thalidomide sales outside the U.S. The European Medicines Agency (EMEA) found that the benefits of the drug in combination with melphalan and prednisone in treating multiple myeloma blood disorders in patients over 65 years of age or ineligible for high-dose of chemotherapy far outweigh the risks related to the initial treatment. The EC usually follows the recommendation of the EMEA.

The marketing approval would require Pharmion to establish a plan for preventing the sale of thalidomide to women who may be pregnant, given the drug’s severe and life-threatening effects on the unborn child.

HPV causing oral cancer in men

Human papillomavirus (HPV), the sexually transmitted virus that causes cervical cancer in women, is fast becoming a major cause of oral cancer in men, according to a study published in the Journal of Clinical Oncology. The number of men becoming afflicted by the cancers of the upper throat via the HPV virus is similar to those who catch the deadly disease due to the consumption of tobacco and alcohol. According to Dr. Maura Gillison, co-author of the study, “If current trends continue, within the next 10 years there may be more oral cancers in the United States caused by HPV than tobacco or alcohol.”

Gardasil LogoMerck & Co.’s Gardasil, the only HPV vaccine in the market and approved by the FDA for young girls and women, may be filed for the FDA approval later this year for use by men.

Birth control pills reduce ovarian cancer risk

The use of oral contraceptives reduces the risk of ovarian cancer, according to a new study published in the Lancet medical journal. The longer women use the pill, which contains progestin or a combination of the estrogen and progestin hormones, the lower is their risk of developing ovarian cancer at a later stage. While the pill is linked to breast and cervical cancer, the risk associated with these is lower than the protection offered by oral contraceptives against ovarian cancer, said study co-author Dr. Valerie Beral of Oxford University’s Cancer Research UK Epidemiology Unit.

Study shows Nexavar raises blood pressure

Nexavar logoA new study has found that Nexavar, a drug used for the treatment of kidney and liver cancer, can substantially raise blood pressure. According to the authors of the study, published in U.K. medical journal Lancet Oncology, patients on Nexavar (sorafenib) should be closely monitored and treated for high blood pressure in order to prevent cardiovascular problems.

Nexavar, which is being co-developed by Bayer AG and Onyx Pharmaceuticals Inc., is now being reviewed for treating small-cell lung cancer, prostate cancer and melanoma. Bayer said the drug’s high-blood-pressure risks are covered by the labeling.

Virginia delays mandatory HPV vaccination for schoolgirls

Virginia State FlagVirginia House has voted for a delay in the mandating of the vaccination of sixth-grade schoolgirls against a sexually-transmitted virus that can cause cervical cancer. The vote was to delay the implementation of the mandatory HPV (human papillomavirus) vaccination to July 2010 from October 2008. Virginia was the first U.S. state to make the vaccination mandatory last year. The delay allows for more time for studying the vaccine’s effects on young girls.

Varian Medical gets 510(k) nod for RapidArc

RapidArcVarian Medical Systems has received an FDA 510(k) approval for its RapidArc radiotherapy technology, which makes it possible to deliver image-guided, intensity-modulated radiation therapy (IMRT) two to eight times faster and more precisely than is possible with conventional IMRT or helical tomotherapy.

RapidArc delivers a complete IMRT treatment in a single rotation of the treatment machine around the patient. The two FDA clearances for RapidArc cover the treatment hardware and the RapidArc treatment planning software module in Varian’s Eclipse treatment planning system. Varian will begin taking orders for RapidArc immediately, and will begin delivering it to customers in the spring of 2008.

Read the full story here.

« Previous Page