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J&J nabs an early OK for 'breakthrough' multiple myeloma blockbuster contender Darzalex

(FierceBiotech) Johnson & Johnson ($JNJ) scored an early FDA approval for its "breakthrough" blockbuster contender daratumumab, earning a swift OK as a new treatment for multiple myeloma four months ahead of the PDUFA date. The drug will be marketed as Darzalex…
Daratumumab is given once a week for the first two months of treatment, then the infusions wind down to once monthly in the second 6 months of the year, says a spokesperson for J&J. For the first full year--with a total of 23 doses given at a cost of $5,850 per infusion--the average monthly wholesale acquisition cost is $11,212, says J&J, or $135,550 for the first year. In year two, and any year thereafter, patients receive a total of 13 doses, for a monthly wholesale cost of $6,337, or $76,044 annually. J&J also offers programs to limit patient's out-of-pocket costs and will be offering payers discounts during price negotiations.
Focusing on the group of patients getting the top dose, investigators reported … last August that the drug scored an impressive 36% overall response rate among 42 patients with late-stage multiple myeloma--a step up from the 29% overall rate that was reported at ASCO earlier in the year.
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