At the end of March, the Committee for Medicinal Products for Human Use (CHMP) announced two positive recommendations for new ways of administering the existing myeloma drugs daratumumab and isatuximab.

Both drugs are monoclonal antibodies used in the treatment of myeloma. Both CHMP recommendations focus on subcutaneous injection, where a medication is injected into the fatty tissue layer between the skin and muscle.

The CHMP is the European Medicines Agency’s (EMA) body responsible for evaluating, authorising, and monitoring human medicines in the EU. A positive recommendation from the CHMP still needs the official approval of the European Commission to be implemented, a process which typically takes around a few months.

The first CHMP decision enables subcutaneous daratumumab (Darzalex®) to be administered at home by patients or carers. The first four doses need to be administered in hospital by a patient or their carer under the supervision of their healthcare professional. After undergoing proper training, the fifth dose can be administered at home by a patient or carer if their healthcare professional considers that it is appropriate.

This applies to all current authorised uses of subcutaneous daratumumab.

For isatuximab (Sarclisa®), the CHMP recommended that the medicine could be administered as a  subcutaneous injection and as a subcutaneous injection through an on-body injector. The on-body injector is a device designed to deliver the medicine with the push of a button and would be the first myeloma medicine delivered this way. Both the subcutaneous injection and on-body injector delivery are done in hospital settings. Isatuximab is currently approved to be administered through intravenous infusion.

If approved, these recommendations will provide patients with more flexible options for the administration of daratumumab and isatuximab.