FW: FDA MedWatch - Revlimid (lenalidomide): Ongoing Safety Review - increased risk of developing new malignancies

[Guest guest]

Revlimid (lenalidomide): Ongoing Safety Review - increased risk of

developing new malignancies

AUDIENCE: Hematology, Oncology

ISSUE: FDA is informing the public that we are aware of results from

clinical trials conducted inside and outside the United States that found

that patients treated with Revlimid (lenalidomide) may be at an increased

risk of developing new types of cancer compared to patients who did not

take the drug.FDA is currently reviewing all available information on this

potential risk and will communicate any new recommendations once it has

completed its review.

BACKGROUND: Revlimid is used to treat a type of blood disorder known as

myelodysplastic syndrome. Revlimid is also used along with other drugs to

treat people with the cancer known as multiple myeloma.

RECOMMENDATION: At this time, there is no recommendation to delay, modify or

restrict the use of Revlimid for patients being treated according to the

FDA-approved indications. FDA is currently reviewing all available

information. on this potential risks and will communicate any new

recommendations once it has completed its review.

Healthcare professionals and patients are encouraged to report adverse

events or side effects related to the use of these products to the FDA's

MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online:

www.fda.gov/MedWatch/report.htm

* Download form or call 1-800-332-1088 to request a reporting form,

then complete and return to the address on the pre-addressed form, or submit

by fax to 1-800-FDA-0178.

Read the complete MedWatch Safety Alert at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMed

icalProducts/ucm250606.htm

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Comment: While concerning, the context here (that I'm aware of) is use of

Lenalidomide following intensive high dose therapy with SCT ... in the trial

described below, the incidence was 15 for Lenalidomide vs. 10 for placebo.

....

http://multiplemyelomablog.blogspot.com/2010/12/more-about-new-revlimid-data

-showing.html

copying: " He said about 8 percent of multiple myeloma patients who are alive

after two years are at risk of developing a secondary cancer.

Moreover, if a patient receives a stem cell transplant, or receives a type

of drug known as an alkylator, such as melphalan, the risk of developing a

secondary cancer is eight times higher than if those elements are not

included in the treatment.

In the trial reported on Sunday, known as CALGB, patients were either given

a high dose of melphalan followed by a stem cell transplant followed by

Revlimid, or were given melphalan, a stem cell transplant and a placebo. "

==

So keep in mind that if the same study was repeated, the incidence of second

malignancies could be very different in the two arms. The association is a

signal to watch for the possibility of a causal effect, it is not evidence

... it could have been coincidental and the risk if it exists could be

specific to that circumstance - use of Lenalidomide after high dose

chemotherapy.

We'll see. And this is another example of why controlled study with

sufficient follow up is needed to measure benefits and risks.

Karl