The US Food and Drug Administration (FDA), this week, approved Daratumumab + Hyaluronidase Fihj (Darzalex FAspro) and Carfilzomib, (Kyprolis), as well as Dexamethasone for patients with relapsed/refractory multiple Myeloma (Kd) for patients who have received at minimum one to three previous lines of therapy.
The new combination in this setting is a time-saver for clinics and patients, said an investigator.
“Subcutaneous daratumumab paired with Kd has been approved by the Mount Sinai Cancer Clinical Trials Office in New York City,” said Ajai Chari in a Janssen press release.
The efficacy studies for the approval are from a single arm cohort of PLEIADES, a multicohort open-label study. The cohort consisted of 66 patients suffering from multiple myeloma relapsed/refractory who had previously received one or more lines of treatment. Patients received daratumumab and hyaluronidase-f subcutaneously, in conjunction with dexamethasone and carfilzomib.
The most important outcome of efficacy was the overall response rate of 84.8%. With a median follow-up period of 9.2 months the median duration of response had not yet been attained.
According to a company press release, the reaction rate for the new combination which also includes subcutaneous injections was similar to the response rate of the previous combination, which includes the longer-lasting IV administration, was FDA approved.
Patients who received Darzalex Faspro and Kyprolis suffered the most severe adverse reactions (>=20%).
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