Bristol-Myers' Revlimid Combo Gets EU Nod For New Indication

Bristol-Myers Squibb Company (NYSE:BMY) announced that the European Commission (EC) has approved a new indication for Revlimid (lenalidomide) in combination with Roche’s Rituxan (rituximab) for the treatmentof adult patients with previously-treated follicular lymphoma (FL).

The approval of Revlimid and Rituxan (R2) was mainly based on results from the phase III AUGMENT study, which evaluated the efficacy and safety of the 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.

In addition to AUGMENT, findings from the MAGNIFY study were included to support the safety and efficacy data on Revlimid plus rituximab in patients with relapsed or refractory FL, including the rituximab refractory FL patients.

Bristol-Myers’ stock has rallied 85.6% year to date compared with the industry’s growth of 9.1%.

We remind investors that R² received approval for previously-treated FL and previously-treated marginal zone lymphoma in May. It was the first FDA-approved combination treatment regimen for patients with these indolent forms of non-Hodgkin’s lymphoma (NHL) that does not include chemotherapy.

Revlimid is approved for the treatment of multiple myeloma. It is also approved for the treatment of patients with mantle cell lymphoma (MCL), whose disease has relapsed or progressed after two prior therapies.

The drug was added to Bristol-Myers’ portfolio after it acquired Celgene (NASDAQ:CELG).

Zacks Rank & Other Stocks to Consider

Bristol-Myers currently has a Zacks Rank #2 (Buy).

A few similar-ranked stocks in the large cap pharma sector are GlaxoSmithKline plc. (NYSE:GSK) , Pfizer Inc. (NYSE:PFE) and Merck & Co. Inc. (NYSE:MRK) . You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GlaxoSmithKline’s earnings per share estimates have increased from $3.00 to $3.25 for 2019 and from $2.99 to $3.11 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 17.23%, on average.

Pfizer’s earnings per share estimates have increased from $2.81 to $2.96 for 2019 and from $2.52 to $2.59 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 8.73%, on average.

Merck’s earnings per share estimates have increased from $4.90 to $5.15 for 2019 and from $5.35 to $5.49 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 12.51%, on average.

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