European regulators approve Johnson & Johnson's Darzalex for second-line multiple myeloma

Johnson & Johnson announced Friday that the European Commission approved Darzalex (daratumumab) for use in combination with Celgene's Revlimid (lenalidomide) plus dexamethasone, or Takeda's Velcade (bortezomib) plus dexamethasone, to treat adults with multiple myeloma who have received at least one prior therapy. The decision follows a positive opinion issued in February by the European Medicines Agency's Committee for Medicinal Products for Human Use recommending broadening the drug's existing EU marketing authorisation.

According to Johnson & Johnson, the approval was based on data from the Phase III POLLUX and CASTOR trials. The POLLUX study enrolled 569 patients who had relapsed or refractory multiple myeloma who were randomly assigned either Darzalex in combination with Revlimid and dexamethasone, or Revlimid plus dexamethasone alone. Meanwhile, the CASTOR study randomised 498 patients with relapsed or refractory multiple myeloma to receive Darzalex combined with Velcade and dexamethasone, or Velcade and dexamethasone alone.

Results showed that the addition of Darzalex significantly reduced the risk of disease progression or death, by 63 percent in POLLUX and 61 percent in CASTOR, when combined with standard of care regimens. Johnson & Johnson also noted that the safety profile of Darzalex in combination with standard therapies was consistent with the drug when tested in monotherapy studies and with that for the standard of care regimens.

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The European regulatory submission was also supported by data from the early-stage MMY1001 study of Darzalex in combination with Celgene's Pomalyst (pomalidomide) and dexamethasone, as well as from the Phase I/II GEN503 study of Darzalex in combination with Revlimid and dexamethasone.

Darzalex already had conditional approval in Europe as monotherapy for adults with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and whose disease has progressed. Johnson & Johnson indicated that this authorisation has now been switched to full approval following its submission of additional data from the POLLUX and CASTOR studies.

The CD38 monoclonal antibody is being developed under a 2012 agreement with Genmab, under which the company granted Johnson & Johnson an exclusive worldwide license to develop and market the product. Genmab indicated that it will receive $48 million in milestone payments from Johnson & Johnson in connection with the first commercial sales of Darzalex under the expanded label. Further, Genmab said sales of the drug "are expected to occur quickly after the approval," adding that the milestone payments were included in its financial guidance issued in February.

Darzalex was approved as monotherapy by the FDA in 2015 for multiple myeloma in patients who received at least three prior treatments. The US label was expanded last year to include use in combination with Revlimid plus dexamethasone, or Velcade plus dexamethasone, for patients with multiple myeloma who have received at least one prior therapy. 

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