Priority review for Genmab’s Darzalex?

There is no sign of a summer slump for Copenhagen-based biotech Genmab. In July, it received BTD for its lead candidate daratumumab (Darzalex), a monoantibody for the treatment of patients with multiple myeloma. Now, together with partner Janssen Biotech Inc (parent Johnson & Johnson), the biotech is filing a supplemental Biologics License Application (sBLA) to the FDA. The application seeks to expand the current indication, using daratumumab in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a proteasome inhibitor) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Janssen has submitted a request for a priority review. If the US agency responds as quickly as it has done previously, the partners could see Darzalex gaining approval before the end of the year.

The significant advance of its myeloma treatment is the second wave of good news that the company has experienced this summer. Only in July, it granted Gilead Sciences license to develop its HIV antibody platform in a deal worth up to €252m.

Darzalex, which was developed by Genmab, is an injection for intravenous infusion for the treatment of patients with multiple myeloma. In Europe, daratumumab is indicated for use as monotherapy in patients who have received at least three prior lines of therapy. In 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialise the antibody. The submission of the sBLA application triggers milestone payments totalling $15m (€13.2m) to Genmab from Janssen. Approval of the sBLA would allow Johnson & Johnson market Darzalex towards a larger proportion of multiple myeloma patients. Its current approval makes Darzalex an almost last resort option for patients who have already tried several other drugs. The submission is based upon data from the Phase III CASTOR and POLLUX studies. These data will also be used as the basis for a potential regulatory submission to the European Medicines Agency (EMA).