GSK's BCMA-Targeted Antibody-Drug Conjugate Receives Unanimous FDA Advisory Committee Support for Relapsed/Refractory Multiple Myeloma
GSK
Pharmaceutical R&D Manufacturer
FDA
U.S. Food and Drug Administration
Oncologic Drugs Advisory Committee
The Oncologic Drugs Advisory Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products used in the treatment of cancer, and provides appropriate recommendations to the Commissioner of Food and Drugs. It accepts requests from the U.S. Food and Drug Administration for technical and clinical evaluations of new drugs. Composed of members from academia and clinical oncology, biostatistics, the public, and the pharmaceutical industry, the Committee offers non-binding recommendations to the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regarding the feasibility of approving new cancer treatments. Members and the Chair are selected by the Commissioner or their designee from among authorities in general oncology, pediatric oncology, hematologic oncology, immuno-oncology, biostatistics, and other relevant professional fields. The core voting membership may include one technically qualified member selected by the Commissioner or their designee, who represents consumer interests and is recommended by a coalition of consumer-oriented organizations or other interested parties. In addition to voting members, the Committee may also include one non-voting member representing industry interests.
GSK announced today that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in support of belantamab mafodotin, an antibody-drug conjugate targeting B-cell maturation antigen (BCMA) developed by the company, determining that its benefits outweigh its risks for the treatment of patients with relapsed/refractory multiple myeloma. These patients must have received at least four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Two committee members were unable to participate in the final vote. Previously, the Biologics License Application (BLA) for belantamab mafodotin had been granted Priority Review by the U.S. FDA. If approved, it could become the first anti-BCMA therapy for these patients.
Multiple myeloma is a malignant hematologic cancer caused by the malignant transformation of plasma cells in the bone marrow. The abnormal proliferation of plasma cells impairs the production of normal blood cells, leading to damage to the bones, immune system, and kidneys. Although various therapies can effectively treat multiple myeloma, tumor cells typically develop resistance to existing treatments and relapse. Therefore, the development of innovative therapies is crucial.
Belantamab mafodotin is one of GSK’s key research and development projects. It conjugates a humanized anti-BCMA antibody with a cytotoxic agent, specifically delivering the cytotoxic payload into multiple myeloma (MM) cells by targeting BCMA to exert its cancer-cell-killing effect. BCMA has emerged in recent years as a highly prominent therapeutic target. It is a transmembrane glycoprotein belonging to the tumor necrosis factor (TNF) receptor superfamily, also known as TNFRSF17 or CD269. A key characteristic of this protein is its high expression on all MM cells, while it is not expressed in other normal tissues (except for plasma cells). Consequently, BCMA has become a popular target for numerous pharmaceutical companies and research institutions developing therapies for patients with relapsed/refractory MM. Previously, belantamab mafodotin received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA).
▲Belantamab mafodotin is a key investigational therapy under development by GSK (Image source: GSK official website)
This recommendation is based on data from the DREAMM clinical trial program, including the pivotal DREAMM-2 study, which enrolled heavily pretreated patients whose disease continued to progress despite receiving current standard of care. The six-month preliminary results of this study were published in Lancet Oncology in December 2019 and served as the basis for the Biologics License Application (BLA).
Dr. Axel Hoos, Senior Vice President and Head of Oncology R&D at GSK, stated: “We are pleased that the Committee has recognized the potential of belantamab mafodotin to help patients with relapsed/refractory multiple myeloma, an incurable disease with limited treatment options. We look forward to working with the FDA to complete the review of our Biologics License Application as soon as possible.”
References:
[1] GSK announces FDA advisory committee votes in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma. Retrieved July 14, 2020, from https://www.gsk.com/en-gb/media/press-releases/gsk-announces-fda-advisory-committee-votes-in-favour-of-positive-benefitrisk-profile-for-belantamab-mafodotin-for-patients-with-relapsedrefractory-multiple-myeloma/
Original Title: Express |GSK’s BCMA Antibody-Drug Conjugate Poised for Approval After Unanimous 12-0 Advisory Committee Vote
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