On 30 November 2021, the US Food and Drug Administration (FDA) approved daratumumab plus hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) and carfilzomib (Kyprolis, Amgen, Inc.) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.<\/p>\n
Efficacy was evaluated in a single-arm cohort of PLEIADES (NCT03412565), a multi-cohort, open-label study. This cohort enrolled 66 patients with relapsed or refractory multiple myeloma who received at least one prior line of therapy. Patients received Darzalex Faspro 1,800 mg\/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously in combination with Kyprolis (20\/70 mg\/m2<\/sup> once weekly regimen) and dexamethasone.<\/p>\n The main efficacy outcome measure was overall response rate (ORR). The ORR was 84.8% (95% confidence interval [CI] 73.9%, 92.5%). At a median follow-up of 9.2 months, the median duration of response had not been reached and an estimated 85.2% (95% CI 72.5, 92.3) maintained response for at least 6 months and 82.5% (95% CI 68.9, 90.6) maintained response for at least 9 months.<\/p>\n The most common adverse reactions (\u226520%) occurring in patients treated with Darzalex Faspro, Kyprolis, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhoea, cough, dyspnoea, headache, pyrexia, nausea, and peripheral oedema.<\/p>\n The recommended Darzalex Faspro dose is 1,800 mg\/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously once weekly from weeks 1 to 8, once every 2 weeks from weeks 9 to 24, and once every 4 weeks starting week 25 until disease progression or unacceptable toxicity.<\/p>\n The recommended dosage regimens of Kyprolis when administered in combination with Darzalex Faspro are the following: <\/p>\n Full prescribing information for Darzalex Faspro is available here<\/a>, and for Kyprolis here<\/a>.<\/p>\n This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment.<\/p>\n Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System.<\/p>\n For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA\u2019s Oncology Center of Excellence<\/a> Project Facilitate<\/a>.<\/p>\n\n