J&J submits sBLA to U.S. FDA seeking approval of DARZALEX FASPRO
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced the first disclosure of data from the Phase 3 CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy, demonstrating noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo. In addition, subcutaneous nivolumab displayed noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo. These results will be featured in a late-breaking oral presentation (Abstract #LBA360) at the American Society of Clinical Oncology (ASCO) 2024 Genitourinary Cancers Symposium from January 25-27, 2024.
Halozyme Announces Takeda Receives FDA Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
SAN DIEGO, Dec. 12, 2023 /PRNewswire/ -- Johnson & Johnson announced today the first data from the Phase 3 PERSEUS study highlighting significant clinical improvement with a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet induction, consolidation regimen and doublet maintenance regimen in the treatment of transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM). The data, showing an unrivaled progression-free survival (PFS) in a Phase 3 study evaluating TE NDMM and clinically significant improvement of rates of overall complete response (CR) or better and minimal residual disease (MRD) negativity over the comparator arm, were featured as a late-breaking oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting (Abstract #LBA-1). The data were published simultaneously in The New England Journal of Medicine.
DAEJEON, South Korea, Sept. 5, 2023 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170), a Korean biotech company announced that their recently concluded clinical trial of Tergase® showed zero incidence of ADA (including neutralizing antibodies). Tergase® is Alteogen's first proprietary product currently under pharmaceutical approval process by the Korean Ministry of Food and Drug Safety.
Bioindustria Laboratorio Italiano Medicinali S.p.A. Fails EDQM Inspection
Janssen Biotech's Biologic Darzalex Faspro Receives Approval in the U.S.
SAN DIEGO, Dec. 1, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with Kyprolis® (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. This approval follows Janssen's regulatory submission to the FDA in February 2021.
Janssen Biotech's Biologic Darzalex Faspro (Daratumab;Hyaluronidase) gets Approval in the U.S.
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval marks Janssen's sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were recently published in The Lancet Oncology.