FDA approves new indication for Darzalex Faspro combo

The US Food and Drug Administration (FDA) yesterday approved daratumumab and hyaluronidase-fihj – trade name Darzalex Faspro - from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech, in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

Efficacy was evaluated in CEPHEUS (NCT03652064), an open-label, randomized, active-controlled trial in patients with newly diagnosed multiple myeloma who were ineligible for ASCT or refused ASCT as initial therapy. The effectiveness of Darzalex Faspro-VRd has not been established in patients who refused ASCT as initial therapy, the FDA noted.