FDA News

FDA grants breakthrough therapy designation to BCMA antibody-drug conjugate for multiple myeloma

The FDA granted breakthrough therapy designation to GSK2857916 for the monotherapy treatment of patients with relapsed and refractory multiple myeloma.

This application for GSK2857916 (GlaxoSmithKline) — an anti B-cell maturation antigen (BCMA) monoclonal antibody drug conjugate — includes patients who have failed at least three prior lines of therapy, including an anti-CD38 antibody, and who are refractory to a proteasome inhibitor and an immunomodulatory agent.

The agency’s decision is based on data from an open-label phase 1 dose-escalation and expansion study that treated patients with relapsed/refractory multiple myeloma, irrespective of BCMA expression, scheduled for presentation at the ASH Annual Meeting and Exposition in December.

“Oncology research and development at GlaxoSmithKline is focused on developing medicines with transformational potential for patients, and we are pleased that our investigational antibody drug conjugate is the first BCMA-targeting agent to receive breakthrough therapy ... designation,” Axel Hoos, senior vice president of oncology research and development at GlaxoSmithKline, said in a company-issued press release. “GlaxoSmithKline plans to rapidly advance clinical trials with this promising therapy, alone and in combination with other therapies, to further investigate how GSK2857916 could benefit patients with multiple myeloma. The monotherapy data that we have seen for GSK2857916 support its transformational potential and we look forward to working with regulators as we progress the development program.”

GSK2857916 has also received orphan drug designation from FDA for multiple myeloma.

The FDA granted breakthrough therapy designation to GSK2857916 for the monotherapy treatment of patients with relapsed and refractory multiple myeloma.

This application for GSK2857916 (GlaxoSmithKline) — an anti B-cell maturation antigen (BCMA) monoclonal antibody drug conjugate — includes patients who have failed at least three prior lines of therapy, including an anti-CD38 antibody, and who are refractory to a proteasome inhibitor and an immunomodulatory agent.

The agency’s decision is based on data from an open-label phase 1 dose-escalation and expansion study that treated patients with relapsed/refractory multiple myeloma, irrespective of BCMA expression, scheduled for presentation at the ASH Annual Meeting and Exposition in December.

“Oncology research and development at GlaxoSmithKline is focused on developing medicines with transformational potential for patients, and we are pleased that our investigational antibody drug conjugate is the first BCMA-targeting agent to receive breakthrough therapy ... designation,” Axel Hoos, senior vice president of oncology research and development at GlaxoSmithKline, said in a company-issued press release. “GlaxoSmithKline plans to rapidly advance clinical trials with this promising therapy, alone and in combination with other therapies, to further investigate how GSK2857916 could benefit patients with multiple myeloma. The monotherapy data that we have seen for GSK2857916 support its transformational potential and we look forward to working with regulators as we progress the development program.”

GSK2857916 has also received orphan drug designation from FDA for multiple myeloma.