On August 7, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported U.S. Food and Drug Administration (FDA) approval of GlaxoSmithKline’s (GSK) BLENREP (belantamab mafodotin-blmf), an antibody-drug conjugate (ADC) targeting B-cell maturation antigen (BCMA) that utilizes Seattle Genetics’ proprietary technology (Press release, Seattle Genetics, AUG 7, 2020, View Source [SID1234563177]). BLENREP was developed and will be commercialized by GSK. The approval triggers a $20 million milestone payment and entitles Seattle Genetics to royalties on BLENREP product sales. BLENREP was approved for the treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.
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"BLENREP is the first BCMA-targeted treatment to be approved by FDA, becoming another first-in-class medicine utilizing our ADC technology for the treatment of patients with cancer," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Notably, this ADC uses our novel mafodotin cell-killing payload. There are now multiple drugs approved by FDA using our ADC technology, and each addresses an important unmet medical need."
In July 2020, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the approval of belantamab mafodotin as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. The CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, which has the authority to approve medicines for use throughout the European Union.
Seattle Genetics’ ADC technology combines the specificity of monoclonal antibodies, innovative linker systems and potent cell-killing agents to treat cancer. The technology has been licensed to several companies. Under the terms of these agreements, each licensee company has rights to use the technology with antibodies against specified targets. The licensee is responsible for research, product development, manufacturing and commercialization. Seattle Genetics is entitled to receive fees, progress-dependent milestone payments and royalties on worldwide net sales of any resulting ADC products.