Skip to content

Celgene’s Orphan Drug Revlimid Receives FDA Approval

June 5, 2013

Celgene announces on June 5, 2013 (scheduled FDA PDUFA date), that the FDA approves the supplemental new drug application (sNDA) for orphan drug Revlimid (Lenalidomide) for Mantle Cell Lymphoma (MCL). The drug is approved for MCL that has relapsed or progressed after two prior therapies, one of which includes Bortezomib. Revlimid is the first oral treatment for MCL. Revlimid is also FDA approved for :

•   Multiple Myeloma (FDA orphan designation)

•   Myelodysplastic Syndromes (FDA orphan designation).

Revlimid has FDA orphan designation for :

•   Diffuse Large B-Cell Lymphoma
•   Chronic Lymphocytic Leukemia.

According to a Reuters article, the FDA approval is “adding another revenue source for the $4 billion-a-year medicine …. Revlimid had sales of $1 billion in the first quarter 2013 … Cowen and Co analyst Eric Schmidt forecast additional annual sales of about $100 million to $200 million from the additional approval ….”

The approval of Revlimid is based on a Phase II (MCL-001), multi-center, single arm, open label study. MCL-001 evaluates Revlimid in 134 MCL patients who receive prior treatment with Rituximab, Cyclophosphamide, and Bortezomib alone or in combination. The primary endpoint of the study is the :

“overall response rate based on a review of radiographic scans by an independent review committee according to a modified version of the International Workshop Lymphoma Response Criteria …. (primary endpoint) was 26% (34/133) (95% CI 18.4, 33.9) with a complete response rate (CR/CRu) of 7% (9/133) (95% CI 3.1, 12.5). The median duration of response was 16.6 months (95% CI, 7.7, 26.7).”   


Celgene Pipeline.

Please Note: FDA Official Logo from FDA website.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s

%d bloggers like this: