Genmab A/S (CPH:GEN), a biotechnology company specialising in the creation and development of differentiated antibody therapeutics for the treatment of cancer, announced on Monday the issue by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a positive opinion recommending updating the existing marketing authorisation for DARZALEX (daratumumab) in the EU.

Reportedly, this recommendation is to update the Summary of Product Characteristics in order to provide health care professionals the option to split the first infusion of DARZALEX over two consecutive days.

This type II variation application was submitted to the EMA by Genmab's licensing partner, Janssen Biotech Inc, in August 2018. In August 2012, Genmab had granted Janssen Biotech an exclusive worldwide license to develop, manufacture and commercialise daratumumab.

According to the company, this positive opinion of the CHMP was based on data from the phase Ib EQUULEUS (MMY1001) clinical trial, which demonstrated daratumumab pharmacokinetics (PK) concentrations were comparable regardless of whether the first dose was administered as a split infusion or as a single first infusion in patients with multiple myeloma. The safety profile of daratumumab was comparable when administered initially as either a split or a single dose.

A CHMP opinion is one of the final steps in the regulatory process of the EMA. A final decision by the European Commission is anticipated within approximately two months.

DARZALEX (daratumumab) injection for intravenous infusion is indicated in the US in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI) and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.