J&J's Darzalex Phase III first-line MM data at ASH to bolster drug’s use in clinical practice immediately, experts say

06 Dec 2018

Johnson & Johnson's (NYSE:JNJ) MAIA Phase III data of Darzalex (daratumumab) in front-line multiple myeloma (MM) could have an immediate impact on clinical practice in the US, experts said on the sidelines of the recently concluded American Association of Hematology (ASH) annual meeting. The trial, which tested Darzalex in combination with Celgene's (NASDAQ:CELG) Revlimid (lenalidomide) and dexamethasone (D-Rd) showed clear superiority to Rd, they noted, anticipating that D-Rd will quickly replace Rd as the standard-of-care (SOC) in first-line MM patients who are ineligible for transplant.

Additionally, with Darzalex already approved as a first-line MM therapy but as part of a different combination, D-Rd has the potential to be prescribed off-label ahead of an expected FDA approval, experts said. The approved Darzalex combination with Takeda Pharmaceutical's (TYO:4502) Velcade (bortezomib), melphalan and prednisone (VMP) has not been commonly used in the US, despite its May first-line approval, noted MAIA investigator Dr Saad Usmani, director, clinical research in hematologic malignancies, Levine Cancer Institute/Atrium Health, Charlotte, North Carolina.

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