Kyprolis and Darzalex Receive Expanded Indications

August 20, 2020 – The U.S. FDA has approved expanded indications for Kyprolis® (carfilzomib – Amgen) and Darzalex® (daratumumab – Genmab). The drugs may now be used together, in combination with dexamethasone, to treat adults diagnosed with relapsed/refractory multiple myeloma (MM) who have received one to three previous lines of therapy.

Multiple myeloma is a cancer of the plasma cells that can lead to anemia (too few red blood cells), thrombocytopenia (too few blood platelets), and leukopenia (too few white blood cells). Additional signs and symptoms include fatigue, easy bruising and bleeding, and reduced ability to fight infections. Relapsed/refractory MM occurs when the disease either returns following treatment or is resistant to treatment.

In clinical studies, the combination of Kyprolis and Darzalex with dexamethasone delivered an overall response rate (ORR) of 84% and a complete response rate (CRR) of 24%, compared to a 75% ORR and a 10% CRR with only Kyprolis and dexamethasone (a current standard of care). Kyprolis plus Darzalex and dexamethasone also improved progression free survival compared to Kyprolis and dexamethasone.

Recommended dosing is based on the patient’s weight and the frequency of treatment, with both once- weekly and twice-weekly dosing regimens available. Dexamethasone must be administered before Kyprolis and Darzalex. Both Kyprolis and Darzalex are administered via intravenous infusion.

Kyprolis first received FDA approval in 2012, while Darzalex received its initial FDA approval in 2015. Both drugs have multiple indications for the treatment of melanoma.