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llllllllll Blenrep (belantamab mafodotin) / GSKFDA approves GSK’s BLENREP (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma (GSK Press Release) - Aug 6, 2020 - "GlaxoSmithKline...announced the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials...The approval of BLENREP was based on six-month primary results from the pivotal DREAMM-2 study..."llllllllll zalifrelimab (AGEN1884) / Recepta, Agenus; balstilimab (AGEN2034) / Agenus, ReceptaAgenus Provides R&D Update & Second Quarter Financial Report (Agenus Inc. Press Release) - Aug 6, 2020 - P1, N=86; NCT03860272; Sponsor: Agenus Inc; "Balstilimab BLA filing to be initiated in current quarter; Zalifrelimab actives responses in PD-1 refractory tumors...Ph2 expansion trial in angiosarcoma underway; AGEN1181 combo w bali achieves CR with both primary and metastatic tumors confirmed by PET scan...Updated Ph1 achieves a total of 2 CRs & clinical benefit (CR/PR/SD) in ~65% patients...Expansion cohorts in NSCLC, MSS tumors, melanoma, and RCC launched"llllllllll omburtamab I-131 (131 I-8H9) / Y-mAbs TherapY-mAbs Announces Completion of Submission of Omburtamab Biologics License Application to FDA (GlobeNewswire) - Aug 6, 2020 - "Y-mAbs Therapeutics, Inc...announced that on August 5, 2020, the Company completed the submission of its Biologics License Application ('BLA') under the FDA’s Rolling Review process for omburtamab...The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present at a venue later this year....'we are currently planning a Phase 2 study for diffuse intrinsic pontine glioma, as we believe omburtamab could potentially be developed for wider compartmental use.'"llllllllll Adaptive Biotechnologies Receives Expanded FDA Clearance for the clonoSEQ Assay to Assess Minimal Residual Disease (MRD) in Patients with Chronic Lymphocytic Leukemia (GlobeNewswire) - Aug 6, 2020 - "Adaptive Biotechnologies Corporation...received clearance from the U.S. Food and Drug Administration (FDA) for its clonoSEQ® Assay to detect and monitor minimal residual disease (MRD) in blood or bone marrow from patients with chronic lymphocytic leukemia (CLL)....Today’s clearance expands the existing FDA-cleared uses of clonoSEQ, as the FDA previously granted the assay De Novo designation for the detection and monitoring of MRD in bone marrow from multiple myeloma and B-cell acute lymphoblastic leukemia (ALL) patients."llllllllll aviptadil intravenous (RLF-100 IV) / Relief Therap, NeuroRxFDA grants inhaled use IND for RLF-100 (aviptadil) to treat patients with moderate and severe COVID-19 aiming to prevent progression to respiratory failure (PRNewswire) - Aug 6, 2020 - "NeuroRx, Inc. and Relief Therapeutics Holdings AG...announced that NeuroRx has been granted Investigational New Drug (IND) permission to test RLF-100 (aviptadil) for inhaled use in patients with moderate and severe COVID-19....The first phase will commence with patients hospitalized for severe COVID-19....The clinical trial of the inhaled formulation of RLF-100 is expected to begin on or before September 1, 2020."
