Saturday, February 25, 2012

Brentuximab - FDA Approved in August 2011- Current Date - 3 Reported Cases of Serious Brain Infection

Another dangerous drug Biologic Therapy -

Approval of this drug was in August 2011 and at that time of approval, there was 1 reported case of PML (serious brain infection) out of 102 participants.  That's a very small amount of participants and out of the 100 people , 1 person ends up with this rare, but very disabling brain infection.  Maybe the FDA should have looked at the number of participants (it's not freaking 500 people and 1 ended up with this rare infection.. making the chances a lot less and a little more reassuring that the drug is safe).
Well, as of January of this year, there are now 3 cases of PML caused by Brentuximab.  This drug should only be prescribed to the sick patient that has exhausted all other options of treatment and the patient has had no success.  If that' the case and you don't have anything to lose, because treating the disease is now a matter of life or death, yes.  I would use that last possible option because at that point there would be no weighing risks versus benefits.  The posed risk is that if the said medication does not work, the chances of survival is slim.
"Brentuximab was approved by the FDA in August 2011 for the treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. At the time of approval, 1 case of PML was described in the warnings and precautions section of the label. So there are now 3 cases associated with the drug.""Brentuximab vedotin (INN, codenamed SGN-35 and previously cAC10-vcMMAE) is an antibody-drug conjugate approved to treat anaplastic large cell lymphoma (ALCL) and Hodgkin lymphoma. The U.S. Food and Drug Administration granted the agent an accelerated approval on August 19, 2011 for use against these two diseases.[1] It is marketed as Adcetris.[2
Accelerated approval basically means the study didn't run the full coarse length of time that would have been necessary to determine the drug's safety and effectiveness.

I wanted to see when the study began,  how long it was supposed to run for and the actual amount of time it did run and was completed.  I went to the reputable site to look up this information for it's accuracy.   This was what I found

Study was supposed to be completed in 7 years from the start date.
Study was completed in a little less than 2 years

2 years is just not enough time when you are trying to determine it's safety!!  How can it be determined in 2 years how the drug may effect the body in the long term.  Even 4 years isn't enough time, but it's still more reasonable and will give more reliable results.  I once again, still don't understand how the FDA could say yes to making this treatment available now.    As we know,  Biologic therapies come with a side-effect profile that is extremely long and with some possibility for long term damage.  Some of the risks that come with these drugs are life threatening. From what is seen in the documentation of reported effects from the use of  Biologic therapies  (ones that have been on the drug market for several years now such as, Remicade, Humira) range from long term nerve damage, severe & life threatening infections,  death.  

Enrollment:102 Participated in Study
Study Start Date:February 2009
Estimated Study Completion Date:August 2015
Primary Completion Date:August 2010 (Final data collection date for primary outcome measure)

FDA Issues Warning About Lymphoma Drug Brentuximab

January 13, 2012 — The US Food and Drug Administration (FDA) has issued a warning to healthcare professionals about the lymphoma drug brentuximab (Adcetris, Seattle Genetics).
Two new cases of progressive multifocal leukoencephalopathy (PML), which is a rare but serious brain infection, have been reported. Because of the seriousness of PML, which can result in death, a new boxed warning highlighting this risk has been added to the drug label, according to the FDA.
In addition, a contraindication was added, warning against the use of brentuximab with the cancer drug bleomycin because of the increased risk for pulmonary toxicity.
Brentuximab was approved by the FDA in August 2011 for the treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. At the time of approval, 1 case of PML was described in the warnings and precautions section of the label. So there are now 3 cases associated with the drug.
The signs and symptoms of PML can develop over the course of several weeks or months. They can include changes in mood or usual behavior; confusion; thinking problems; loss of memory; changes in vision, speech, or walking; and decreased strength or weakness on one side of the body, the FDA says.
Healthcare professionals should suspend brentuximab dosing if PML is suspected, and discontinue the drug therapy if a diagnosis of PML is confirmed, according to the FDA.
Brentuximab generated much excitement among experts when study results were presented at the American Society of Hematology annual meeting in 2010. Some of the responses seen in refractory lymphoma were described as "amazing." The new drug is the first to be approved by the FDA for Hodgkin's lymphoma in more than 30 years, the company said.
More information about today's FDA announcement is available on the agency's Web site.
To report adverse events related to brentuximab, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

1 comment:

  1. There are hardly any drugs without side effects, but I don't agree about a drug being rushed to the market without proper testing, especially that the side effects is an often fatal brain disease. Progressive multifocal leukoencephalopathy treatments are rarely successful, so this risk might not just worth taking, unless you have no other option. I read several FDA warnings, where they say "rare, but serious". There are several drugs on the market that triggered PML, so the "rare" might not be so rare anymore, unfortunately.