GSK/Genmab leukaemia drug joins FDA speed lane
pharmafile | September 16, 2013 | News story | Research and Development, Sales and Marketing | Arzerra, GSK, Genmab, Levact, MabThera, chronic lymphocytic leukaemia
GlaxoSmithKline and partner Genmab have been granted ‘breakthrough therapy’ designation by the FDA for their blood cancer drug Arzerra.
Specifically, the US regulator is considering Arzerra (ofatumumab), in combination with chemotherapy agent chlorambucil, for patients with chronic lymphocytic leukaemia (CLL) who have not received prior treatment, and are inappropriate for fludarabine-based therapy.
This will bump up the drug’s use for patients with the disease, as it is currently only approved in a second-line setting.
The FDA’s breakthrough therapy designation is the newest of the FDA’s programmes that looks to speed up its review times for medicines aimed at serious or life-threatening conditions. It could now be approved within six months if all goes well for the firms.
GlaxoSmithKline licensed the drug with Genmab three years ago in a deal worth $2.1 billion. It will hope a new licence can add to the fairly meagre $100 million in sales it brought in last year.
But this could still be an uphill struggle as, if approved, the drug will still need to compete with Napp’s CLL drug Levact (bendamustine) and Roche’s big-selling MabThera (rituximab) – sold as Rituxan in the US – which has a licence for CLL, as well rheumatoid arthritis and non-Hodgkin’s lymphoma. It made nearly $7 billion last year.
Dr Kathy Rouan, VP and head of biopharmaceutical development at GlaxoSmithKline, said: “We are exceedingly proud to receive the Breakthrough Therapy designation, the second this year for GSK. This FDA programme is intended to expedite not just the development but also the review of drugs for serious or life threatening conditions.
“We are actively working on our submission and look forward to the enhanced regulatory interaction allowed for breakthrough therapies.”
CLL is the most common form of leukaemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the US alone in 2013.
Jan van de Winkel, chief executive of Genmab, said: “Both of Genmab’s lead products, ofatumumab and daratumumab, have now been granted breakthrough therapy designations from the FDA. This designation for ofatumumab reflects Genmab’s mission to create differentiated products aimed at improving the lives of patients suffering from debilitating diseases and for whom existing treatments are inadequate.”
Ben Adams
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