November 2019, Vol 9, No 11
On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen Biotech), in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone, for first-line treatment of multiple myeloma in patients eligible for autologous stem-cell transplant (ASCT). In June 2019, the FDA approved the combination of daratumumab plus lenalidomide (Revlimid) and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT. The FDA granted this application a priority review. Read Article ›
On October 23, 2019, the FDA approved niraparib (Zejula; Tesaro), a poly (ADP-ribose) polymerase inhibitor, for the treatment of patients with advanced homologous recombination deficiency (HRD)-positive ovarian, fallopian tube, or primary peritoneal cancer who have received ≥3 previous lines of chemotherapy. The FDA used its priority review program for this approval. Read Article ›
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