The EC approval enables to use of BLENREP as monotherapy to treat multiple myeloma in adult patients who have secured at least four prior therapies including one proteasome inhibitor, one immunomodulatory agent and an anti-CD38 monoclonal antibody.
Earlier this month, the company secured FDA approval for BLENREP for the treatment of relapsed and refractory multiple myeloma.
BLENREP is an antibody-drug conjugate, which includes a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker.
GSK licenced the drug linker technology from Seattle Genetics. BioWa’s POTELLIGENT technology has been licenced to produce monoclonal antibody.
The EC approval was based on data from the DREAMM-2 study, which showed that treatment with single-agent BLENREP enabled to generate an overall response rate of 32%.
DREAMM-2, an open-label study, randomised the patients in two arms to receive either 2.5 mg/kg or 3.4 mg/kg BLENREP Q3W.
GSK R&D president and chief scientific officer Dr Hal Barron said: “The approval of BLENREP marks an important step forward for patients in Europe where nearly 50,000 new cases of multiple myeloma are diagnosed each year.
“Unfortunately, most of these patients will relapse or stop responding to current therapies so I am pleased that today’s news will give patients with limited treatment options access to the first approved anti-BCMA therapy.”
In February this year, GSK collaborated with the Coalition for Epidemic Preparedness Innovations (CEPI) for the development of a vaccine for the novel coronavirus.
Under the deal, GSK will provide its pandemic vaccine adjuvant technology to enhance the development of an effective vaccine against the novel coronavirus.