Monday, March 28, 2011

Ipilimumab approved!!!

The long wait is over. The Food and Drug Administration has approved ipilimumab – the first drug ever proven to prolong survival in stage IV melanoma – in a down-to-the wire decision announced by the agency on March 25.

The approved indication in unresectable and metastatic melanoma comes with a risk management plan addressing life-threatening toxicity associated with the new immunotherapy, as was seen in a pivotal clinical trial conducted in previously treated patients.

Ipilimumab is the first FDA-approved treatment “to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment, Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, noted in the announcement.

It is being marketed by Bristol-Myers Squibb under the trade name Yervoy. The approved dose is 3 mg/kg administered intravenously over 90 minutes every 3 weeks for a total of four doses. That the FDA did not specify a line of therapy “is extremely important and … will open the floodgates to this drug,” Dr. Jeffrey Sosman, Ingram Professor of Cancer Research, professor of medicine, and director of the melanoma program at Vanderbilt University, Nashville, said in an interview after the announcement.

“Most people with metastatic melanoma will see this drug,” said Dr. Sosman, coauthor of the pivotal trial and associate editor of The Oncology Report. The indication does not exclude untreated patients, he noted. A monoclonal antibody administered intravenously, ipilimumab blocks cytotoxic T-lymphocyte antigen (CTLA-4), a molecule that the FDA said “may play a role in slowing down or turning off the body’s immune system, affecting its ability to fight off cancerous cells … [and] may work by allowing the body’s immune system to recognize, target, and attack cells in melanoma tumors.” It is being studied in other cancers as well.

Approval was based on an international study of 676 patients with previously-treated unresectable stage III or IV melanoma whose disease had progressed. The study compared ipilimumab treatment with an experimental tumor vaccine (gp100), gp100 alone, and ipilimumab alone. Median overall survival was 10 months among those who received ipilimumab plus the vaccine, 10.1 months among those who received ipilimumab alone, and 6.4 months among those who received the vaccine alone (N. Engl. J. Med. 2010;363:711-23).

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randi said...

I hope we will see this drug soon. I read that until medicare approves this no one will pay for this drug because of costs. There is a good article about whats to come with this drug
randi-las vegas

Peter said...

Hi. My Wife Sarah Has Stage 4 melanoma. Diagnosed in June of 2010. Did 2 rounds of IL-2, 3 rounds of Carbo-Taxol, Gamma Knife for 6 brain mets and emergency neurosurgery for a bleeding brain met resulting in a stroke. She Began Ipi 3 weeks ago and will be getting her 2nd dose Tomorrow.

A visitor to our caringbridge page linked your site as she felt our families had much in common.

Please visit our site, as I think you will find we do:

All our Best,
Peter Bach

Alisa said...

I have just been reading your blog and am sending prayers your way. I hope ipi is just the thing for you! Thank you for your words of encouragement and hope. Good luck!