As Lenalidomide moves closer to clinical approval for additional indication, what is the likelihood that the drug will be approved?

Lenalidomide is under clinical development by Bristol-Myers Squibb and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Lenalidomide’s likelihood of approval (LoA) and phase transition for Peripheral T-Cell Lymphomas (PTCL) took place on 06 Oct 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Lenalidomide LoA and PTSR Report.

Lenalidomide overview

Lenalidomide (Revlimid) is a thalidomide analogue and an immunomodulatory imide drug (IMiD). It is formulated as hard gelatin capsules for oral route of administration. Revlimid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM), as maintenance therapy in patients with multiple myeloma  following autologous  hematopoietic stem cell transplantation ( auto-HSCT), is indicated for the treatment of  patients with transfusion-dependent anemia due to low -or intermediate -1- risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Revlimid is indicated for the treatment of relapsed or refractory multiple myeloma, in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who are not eligible for stem cell transplant and adult T-cell leukemia-lymphoma. Revlimid in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL), and marginal zone lymphoma (MZL).

Lenalidomide is under development for the treatment of small lymphocytic leukemia (SLL), acute and chronic adult T-cell leukemia/lymphoma, monoclonal B cell lymphocytosis, plasma cell leukemia, relapsed/refractory mantle cell lymphoma, ABC-subtype diffuse large B-cell lymphoma (first-line), relapsed/refractory indolent lymphoma, primary and secondary CNS lymphoma, peripheral T-cell lymphoma, anaplastic large cell lymphoma, chronic lymphocytic leukemia (maintenance, second-line), and in combination with rituximab in relapsed or refractory follicular and mantle cell lymphoma. It was also under development for splenic marginal zone lymphoma, extranodal marginal zone, nodal marginal zone lymphoma, B-cell chronic lymphocytic leukemia (first line), mantle cell lymphoma (first line), diffuse large B-cell lymphoma (maintenance therapy), hormone refractory prostate cancer, cutaneous T Cell Lymphoma, metastatic melanoma, complex regional pain syndrome, radiculopathy, metastatic renal cell carcinoma, Crohn’s disease, ovarian cancer and peritoneal cancer, relapsed or refractory non-hodgkin lymphoma and immunoglobulin G4-related disease (IgG4-RD). It was under development for the treatment of non-deletion 5q myelodysplastic syndrome and follicular lymphoma, acute myelocytic leukemia (AML), papillary thyroid cancer and follicular thyroid cancer, Waldenstrom macroglobulinemia, non-small cell lung cancer, urothelial cell carcinoma, non-muscle-invasive transitional cell bladder cancer, T-cell angioimmunoblastic lymphoma (AITL), myelofibrosis and peripheral T-cell lymphoma (PTCL).

Bristol-Myers Squibb overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in New York City, New York, the US.

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