Celgene Corporation announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Revlimid (lenalidomide) in combination with Roche Holding AG’s (RHHBY - Free Report) Rituxan (rituximab) (anti-CD20 antibody) (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). If approved by the European Commission (EC), R2 will be the first combination treatment regimen for patients with FL that does not include chemotherapy.
The CHMP positive opinion was mainly supported by results from the randomized, multi-center, double-blind, phase III AUGMENT study, which evaluated the efficacy and safety of the R² combination versus Rituxan plus placebo in patients with previously treated FL. Per the study, patients treated with R2 showed statistically significant improvement in the primary endpoint of progression-free survival (PFS), as evaluated by an independent review committee, compared with Rituxan plus placebo.
Revlimid, an oral immunomodulatory drug, in combination with Rituxan leads to immune-mediated treatment effects and represents a chemotherapy-free treatment option that can help patients with previously treated FL and marginal zone lymphoma(MZL) delay disease progression.
Celgene’s stock has surged 71.7% year to date compared with the industry’s growth of 2.3%.
We remind investors that in May, the FDA approved Revlimid in combination with a rituximab product (R²) for the treatment of adult patients with previously treated FL or MZL) following Priority Review designation.. This is the first FDA-approved combination treatment regimen for patients with these indolent forms of non-Hodgkin’s lymphoma (NHL) that does not include chemotherapy.
Celgene’s key growth driver, Revlimid, is currently approved for several indications, including multiple myeloma (MM), myelodysplastic syndromes (MDS) and mantle cell lymphoma (MCL).
Zacks Rank & Other Stocks to Consider
Celgene currently has a Zacks Rank #2 (Buy).
A few other top-ranked stocks in the biotech sector are Alkermes Plc. (ALKS - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80% on average.
Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.36 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31% on average.
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