Celgene Provides Regulatory Update

More Topics: Choose a Sector Accounting Firms Advertising/Media/Communications Capital CEO/Board General Business Health/Biotech Internet/Technology Investment Firms Law Firms Mergers & Acquisitions Money Managers People Private Companies Public Companies Venture Capital

Posted June 21, 2012

Application for new indication for REVLIMID (lenalidomide) in newly-diagnosed and maintenance multiple myeloma has been withdrawn from CHMP; Plans to re-submit with more mature data

Pomalidomide NDA for patients with relapsed and refractory multiple myeloma accepted for standard review by U.S. FDA, PDUFA date set for Feb. 10, 2013; MAA for patients with relapsed and refractory multiple myeloma submitted to the EMA

2012 guidance and 2015 financial targets reaffirmed

Conference call to be held at 8:30 a.m. EDT, available by webcast

BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Srl, 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.

Read the original post:
Celgene Provides Regulatory Update