Author Archives: Patricia Inacio PhD

Janssen Seeks Approval of Darzalex Add-on for Newly Diagnosed Multiple Myeloma Patients in Japan

Janssen has submitted an application to Japanese authorities seeking the approval of Darzalex (daratumumab) — in combination with standard Revlimid (lenalidomide) and dexamethasone — for the treatment of newly diagnosed multiple myeloma patients ineligible for high-dose chemotherapy and stem cell transplant. The supplemental new drug application, which will be considered under priority review, is based on…

Janssen Seeks Darzalex Approval for Certain Newly Diagnosed Multiple Myeloma Patients in Japan

Janssen Pharmaceutical has submitted an application to Japanese authorities requesting that Darzalex (daratumumab) be approved, in combination with standard therapy, to treat newly diagnosed multiple myeloma patients who cannot receive a stem cell transplant. The supplemental new drug application (sNDA), which will be considered under a priority review, is based on data from…

Triple Combo Therapy May Slow Smoldering Multiple Myeloma Progression into Overt Myeloma, Phase 2 Trial Shows

Early treatment with a triple combination therapy containing Empliciti (elotuzumab), Revlimid (lenalidomide), and dexamethasone in patients with smoldering multiple myeloma — a precursor of multiple myeloma — may halt the disease’s progression into the full-blown condition, a Phase 2 trial shows. The results were presented at the American Society…