Celgene's Revlimid-Rituximab Combo Gets FDA Nod for Lymphoma

Celgene Corporation CELG announced that the FDA approved Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL).

R2 previously received Priority Review designation from the FDA. With the approval, this combination regimen will be the first treatment option for patients with indolent forms of non-Hodgkin lymphoma (NHL) that does not include chemotherapy. Indolent lymphomas, which account for about 40% of all NHL cases, are slow-growing forms of the disease, which can often be asymptomatic or have fewer symptoms upon diagnosis. Most patients with indolent forms of NHL will relapse or become refractory to their current treatment, according to Celgene.

Revlimid, an oral immunomodulatory drug,in combination with R2 leads to immune-mediated treatment effects and represents a chemotherapy-free treatment option that can help patients with previously treated FL and MZL delay disease progression. Celgene’s key growth driver, Revlimid, is currently approved for several indications, including multiple myeloma (MM), myelodysplastic syndromes (MDS) and mantle cell lymphoma (MCL). 

The approval of R2 is based on data from the phase III AUGMENT study, evaluating the safety and efficacy of the combination regimen compared with rituximab plus placebo in patients with previously-treated FL and MZL. 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 rituximab plus placebo.

Shares of Celgene have surged 48.6% year to date compared with the industry’s growth of 1.1%.

A Marketing Authorization Application for R2 is currently under review by the European Medicines Agency for the treatment of relapsed/refractory FL and MZL. A supplemental new drug application was also submitted to the Japanese Pharmaceuticals and Medical Devices Agency for an additional indication along with dosage and administration updates for Revlimid in combination with rituximab for the treatment of relapsed/refractory indolent B-cell NHL.

Meanwhile, the current focus is on the company’s impending merger with Bristol-Myers Squibb Company BMY. In January, Bristol-Myers announced that it will acquire Celgene for approximately $74 billion, on receipt of approval from all the shareholders. Bristol-Myers earlier announced that independent proxy advisory firms, Institutional Shareholder Services (“ISS”) and Glass Lewis & Co. (“Glass Lewis”) recommended that shareholders should vote in favor of the approval of the impending merger with Celgene. The merger is expected to close in the third quarter.

The acquisition announcement prompted quite a few other deals. Another leading biotech Biogen BIIB announced that it will acquire Nightstar Therapeutics. Swiss pharma giant Roche RHHBY announced that it will acquire Spark Therapeutics for $5 billion.


Celgene Corporation Price


Celgene Corporation Price

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Zacks Rank

Celgene currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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