LONDON (Reuters) – GlaxoSmithKline received a boost for its oncology research on Thursday when an experimental drug for blood cancer received a “breakthrough” designation from U.S. regulators.
The decision by the Food and Drug Administration paves the way for a speedy regulatory review of the BCMA drug for multiple myeloma. It follows similar priority treatment granted by the European Medicines Agency last month.
Although GSK sold its marketed cancer drugs to Novartis in 2015, it continues to invest in early-stage research and has said oncology could become another pillar of its pharmaceuticals business, alongside HIV and respiratory medicine.
The actions by the U.S. and European regulators are based on promising Phase I clinical trial results, details of which will be announced on Dec. 11 at the annual meeting of the American Society of Hematology meeting in Atlanta.
GSK said it planned a rapid program of clinical trials with the new drug, both alone and in combination with other therapies.
Reporting by Ben Hirschler; Editing by Mark Potter
November 2, 2017