J&J eyes Darzalex convenience, safety boost with subcutaneous win

fiercepharma | June 03, 2019

Right now, the first infusion of Johnson & Johnson multiple myeloma fighter Darzalex can take between seven and eight hours. But data on a new formulation could be a game changer. At the American Society of Clinical Oncology annual meeting, the New Jersey drugmaker trumpeted results from a phase 3 study showing that a subcutaneous form of Darzalex could measure up to the original and with an average injection time of just five minutes. At a median 7.5 months of follow-up, 41% of patients in the head-to-head study which enrolled relapsed or refractory patients had seen benefits after receiving the subcutaneous drug, while 37% of those taking the infused drug could say the same. And without skimping on efficacy, subcutaneous Darzalex recorded a big win, too. Only 12.7% of patients receiving the subcutaneous drug experienced infusion-related side effects a big drop from the 34.5% of patients in the control group who reported them. Majorly cutting down on the time it takes to administer Darzalex could help not just patients, but healthcare providers, too, Tendler said. There are “a lot of nursing staff and personnel that are watching the patient closely with the first infusion,” he said. And if that first dose can wrap up in three to five minutes, “you could free up resources in the office for other things.”As Credit Suisse analyst Vamil Divan pointed out in a note to clients, though, post-administration reactions took longer to show up in subcutaneous patients, with average onset times of 3.6 hours versus 1.5 hours meaning additional monitoring may still be required. “The [new formula] should help address the prolonged infusion time that is needed for the IV formulation, although it was noted in the discussion that for the first subcutaneous dose an observation time of about 3-4 hours may still be needed,” he wrote.

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