FDA Breakthrough designation for GSK's blood cancer drug candidate

Following a similar “PRIME” approval for its blood cancer candidate last month from the European Medicines Agency, GlaxoSmithKline (LSE: GSK) has now received Breakthrough Therapy designation from the US Food and Drug Administration for GSK2857916 monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy, including an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent.

Although GSK pulled out of the main cancer drug market in 2015, selling the business to Swiss pharma giant Novartis (NOVN: VX) in a multi-billion dollar swap deal, it has continued to invest in early-stage research and has said oncology could become another pillar of its pharma business.

Analysts at Liberum recently described the product as “a potential blockbuster”, meaning they expect it may achieve more than £1 billion (~$1.3 billion) in sales.