Policy & Regulation
Seattle Genetics Achieves Milestone Payment Under Antibody-Drug Conjugate Collaboration with GlaxoSmithKline Triggered by Blenrep FDA Approval
7 August 2020 - - The US Food and Drug Administration has approved GlaxoSmithKline's (LSE: GSK) Blenrep (belantamab mafodotin-blmf), an antibody-drug conjugate targeting B-cell maturation antigen that utilizes Seattle Genetics' proprietary technology, US-based Seattle Genetics, Inc. (NASDAQ: SGEN) said.

Blenrep was developed and will be commercialized by GSK.

The approval triggers a USD 20m 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.

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.

Seattle Genetics is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people's lives.

Adcetris (brentuximab vedotin) and Padcev (enfortumab vedotin-ejfv) use the company's industry-leading antibody-drug conjugate technology.

Adcetris is approved in certain CD30-expressing lymphomas, and Padcev is approved in certain metastatic urothelial cancers. Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor, is approved in certain HER2-positive metastatic breast cancers.

The company is headquartered in the Seattle, Washington area, with locations in California, Switzerland and the European Union.