Amneal Receives FDA Approval for Lenalidomide Capsules

The FDA has accepted Amneal’s Abbreviated New Drug Application for 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg lenalidomide capsules, according to a press release from the biopharmaceutical company.¹

Lenalidomide is indicated to treat multiple myeloma (MM) in combination with dexamethasone, as maintenance therapy for MM following autologous hematopoietic stem cell transplant, and for transfusion-dependent anemia due to myelodysplastic syndromes. Adverse reactions to lenalidomide include neutropenia, thrombocytopenia, and leukopenia.

“The approval of lenalidomide represents another key product approval in a large market that will be a future growth driver for us,” said Andy Boyer, Executive Vice President and Chief Commercial Officer of Affordable Medicines at Amneal, in the press release.

The drug is also being evaluated as combination therapy for other blood cancers, including follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, and central nervous system lymphoma.² A study presented at the 66th American Society of Hematology Annual Meeting & Exposition found that lenalidomide 25 mg once daily plus zanubrutinib 160 mg twice daily had a manageable safety profile and promising efficacy in patients with relapsed or refractory DLBCL. The overall response rate was 58%, with 42% achieving complete response. Grade 3 or higher treatment-emergent adverse events occurred in 74% of patients; most commonly, neutrophil count decreased, white blood cell count decreased, and lymphocyte count decreased.³

References

1. Amneal Launches Mesalamine and Receives U.S. FDA Approval for Lenalidomide. News release. Amneal. February 19, 2025. Accessed February 20, 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Launches-Mesalamine-and-Receives-U.S.-FDA-Approval-for-Lenalidomide/default.aspx
2. Clinical Trials Using Lenalidomide. National Cancer Institute. https://www.cancer.gov/research/participate/clinical-trials/intervention/lenalidomide. Accessed February 20, 2025.
3. Song Z, Cheng Y, Yang H, et al. Final analysis of a phase 1 study of zanubrutinib plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma. Abstract presented at: 66th American Society of Hematology Annual Meeting & Exposition; December 7-10, 2024; San Diego, CA.