GSK gets boost for early cancer hopes with breakthrough status

GlaxoSmithKline received a boost for its oncologyresearch on Thursday when an experimental drug for blood cancerreceived 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 programme of clinical trials with the new drug, both alone and in combination with other therapies.


Popular posts from this blog

EMA Recommends Extension of Indications for Ramucirumab

Dr. Hootie Warren takes helm of Fred Hutch Global Oncology

Is Indian pharma ready to tap the European market?