Application for Celgene's (CELG) New Indication for Revlimid Withdrawn

June 21, 2012 7:34 AM EDT Send to a Friend
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Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), is providing a regulatory update for REVLIMID (lenalidomide) and pomalidomide as treatments for multiple myeloma.

We have decided to withdraw the new indication submission to the Committee for Medicinal Products for Human Use (CHMP) for REVLIMID (lenalidomide), which was intended for the maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with melphalan, prednisone and REVLIMID (lenalidomide), or maintenance therapy following autologous stem cell transplantation.

In response to the CHMP’s request, we plan to re-submit with more mature data, which allows CHMP to conclude a clear benefit/risk ratio.

We are proceeding with submissions for REVLIMID (lenalidomide) in newly diagnosed multiple myeloma in Switzerland, Australia and other core markets. In the U.S., we are currently re-evaluating our REVLIMID (lenalidomide) newly diagnosed submission to FDA and anticipate submitting an application in 2013.

Our new drug application (NDA) for pomalidomide plus low-dose dexamethasone for patients with relapsed and refractory multiple myeloma was accepted for standard review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of Feb. 10, 2013.

We are seeking approval to market pomalidomide in combination with low-dose dexamethasone as a potential treatment for relapsed and refractory multiple myeloma patients who have received at least two prior therapies of established benefit, including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy. The NDA is based on data from a phase II study (MM-002) of pomalidomide. Results from this study were most recently presented at the 2012 American Society of Clinical Oncology annual meeting. Our international, randomized, placebo-controlled phase III study (MM-003), in relapsed and refractory multiple myeloma is anticipated to complete enrollment this July. Data are expected by the end of this year.

We have submitted a Marketing Authorisation Application (MAA) for pomalidomide in combination with dexamethasone to the EMA for the treatment of patients with relapsed and refractory multiple myeloma.


The company reaffirmed FY12 and FY15 guidance.


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