New FDA Approval in Multiple Myeloma Treatment

On 20 August 2020, the United States Food and Drug Administration (FDA) approved, for adults with relapsed or refractory multiple myeloma who had received one to three prior lines of treatment, the use of karfilzomib and daratumumab with dexamethasone.

Two clinical trials evaluated the effectiveness of karfilzomib and daratumumab with dexamethasone, and their results led to a new treatment approval for multiple myeloma.

One trial (CANDOR) enrolled a total of 466 patients divided into two groups: 312 patients were treated with karfilzomib, daratumumab and dexamethasone, while 154 received only karfilzomib and dexamethasone. Both groups consisted of adults with relapsed or refractory multiple myeloma who had received one to three prior lines of treatment. To determine treatment effectiveness, the researchers assessed progression-free survival and determined that it was 15.8 months in the doublet-treatment group. The other clinical trial (EQUULEUS) used a similar treatment plan. In the triplet-treatment group, an overall response rate of 81% was found, while response to treatment lasted 27.5 months .

The most common adverse effects observed during clinical trials in at least 20% of patients treated with karfilzomib and daratumumab were the following side effects: infusion-related reactions, anemia, diarrhea, fatigue, hypertension, excessively elevated body temperature (pyrexia), respiratory tract infection, thrombocytopenia, neutropenia, lymphopenia, cough, shortness of breath, insomnia, headache and back pain.