Celgene Corp. (NASDAQ: CELG) announced that the U.S. Food and Drug Administration (FDA) expanded the existing indication for Revlimid in conjunction with dexamethasone. This would go toward treating patients that were newly diagnosed with multiple myeloma. The approval was based on safety and efficacy results of Phase 3 studies.

The approval of Revlimid as an option for use in all patients with multiple myeloma is considered a new paradigm in the management of this disease. The clinical evidence gained from recent trials has shown that Revlimid significantly improves progression-free survival.

Currently, Celgene has an application that is under review by the European Medicines Agency (EMA) for Revlimid in regards to the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. The EMA’s Committee for Medicinal Products for Human Use (CHMP) published a positive opinion for this application in December 2014.

Jacqualyn A. Fouse, Ph.D., President, Global Hematology and Oncology for Celgene, said:

At Celgene, we are very happy with the FDA’s decision, which adds information on the use of REVLIMID plus dexamethasone as a first-line treatment for multiple myeloma to the prescribing information. Now, as part of our commitment to improving the lives of patients living with this disease, our next step is to make the benefits of this treatment regimen available to those now eligible under the expanded indication.

Celgene is one of Wall Street’s top picks for this year, as many feel this large cap stock has solid upside potential for 2015 and an outstanding partnered pipeline. Some analysts think the company can grow earnings 20% or more this year and in 2016.

Shares of Celgene were up 1.7% at $118.24 in the last couple hours of trading on Wednesday. The stock has a consensus analyst price target of $136.74 and a 52-week trading range of $66.85 to $124.60.

ALSO READ: 4 Blue-Chip Biotech Stocks to Buy for the Rest of 2015

Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.