The U.S. Food and Drug Administration (FDA) approved Celgene’s Revlimid (lenalidomide) in combination with a rituximab product for adults with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL). It is the first FDA-approved combination therapy for patients with these forms of non-Hodgkin’s lymphoma (NHL) that doesn’t include chemotherapy. The combination is dubbed R2.
For its current indications, such as multiple myeloma, Revlimid brought in almost $10 billion in 2018. However, in some markets it is facing generic competition. The first generic is expected in March 2022.
In April, Bristol-Myers Squibb’s shareholders voted to approve the acquisition of Celgene for $74 billion. The bid had been announced on January 3, 2019. However, one of its biggest shareholders, Wellington Management Company LLP, objected to the acquisition. Wellington owns about an 8% stake in Bristol-Myers. Another BMS shareholders, Starboard Value, also opposed the deal. Starboard has about a 1% ownership share. The deal is expected to close in the third quarter of this year.
Meghan Gutierrez, chief executive officer for the Lymphoma Research Foundation, stated about the Revlimid-rituximab approval, “Chemotherapy continues to be a standard of care for indolent forms of NHL, but most patients will relapse or become refractory to their current treatment. This approval represents a new therapeutic option for previously treated patients with follicular and marginal zone lymphomas, including those who relapse or no longer respond to initial treatment. We commend the patients and scientists who participated in the clinical study for advancing lymphoma research and treatment.”
The approval for the Revlimid-rituximab combo was based mostly on data from the Phase III AUGMENT trial, comparing the combination against placebo. Patients receiving the combination showed a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to rituximab-placebo. The median PFS was 39.4 months for patients receiving the combination and 14.1 months for those receiving rituximab-placebo.
The trial was not designed to detect a difference in overall survival (OS), but a numeric trend for improvement in OS was observed with the combination compared to rituximab-placebo.
The combination is currently being reviewed by the European Medicines Agency (EMA) for 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 in addition to dosage and administration updates for Revlimid in combination with retuximab for relapsed/refractory indolent B-cell NHL.
“Nearly 15 years following the initial FDA approval, Revlimid continues to demonstrate benefits for new patient populations,” stated Jay Backstrom, Celgene’s chief medical officer. “Revlimid in combination with rituximab leads to immune-mediated treatment effects and represents a chemotherapy-free treatment option that can help patients with previously treated follicular lymphoma and marginal zone lymphoma delay disease progression.”
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