FDA delays Glaxo cervical cancer vaccine ruling
The US FDA was expected to make its decision on the market application of Cervarix, a vaccine for cervical cancer developed by the UK pharma company GlaxoSmithKline (GSK) this week. However, the US regulatory body has decided to delay its ruling. The delay is speculated to be connected to an incident this week wherein a 14-year old British girl died just a few hours after receiving the vaccine. However, preliminary reports indicate that vaccination was unlikely to have been the cause of the girl’s death. She was apparently suffering from underlying medical conditions.
Cervarix has already been approved for marketing in many countries and has been in use in the UK since last year. Its main competitor is Gardasil of the company Merck which is already being used in the US.
Avastin Breast Cancer Trial Enrollment Halted
Another blow to Avastin and its manufacturer Roche. The U.S. National Cancer Institute and the U.S. Eastern Cooperative Oncology Group have informed the drug company that enrolment of its late stage Avastin clinical trial for breast cancer is suspended until further notice. The reason for the suspension is that 6 trial patients with early-stage breast cancer presented with clinical signs of congestive heart failure. Those who are already in the trial and on the drug should continue but should be closely monitored.
New studies prompt rethink on radon risk
Radon is a colorless, odourless, and tasteless gas that is linked to lung cancer. It is also found in nature and in many homes. The radon-cancer link has never been supported by convincing data until now. A report from the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) based on 20 studies of tens of thousands of lung cancer patients provides the missing piece of the puzzle. And indeed the threat is for real and even more dangerous than previously thought. The World Health Organization (WHO) has now recommended new allowable radon limit which is much lower that previously set.
FDA Approves First Drug for Treatment of Peripheral T-cell Lymphoma
The US FDA approved last week the first drug to treat peripheral T-cell lymphoma (PTCL). PTCL is an aggressive type of non-Hodgkins lymphoma. The drug Folotyn (pralatrexate) is indicated for patients who have relapse or do not respond to other forms of chemotherapy. It is manufactured by Allos Therapeutics Inc. of Westminster, Colo.
Health chats at Cleveland Clinic
Tuesday, October 13, 2009 – 12 Noon
Prostate Cancer: What’s the Right Treatment For Me?
with Robert Stein, MDand Jay Ciezki, MD
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