GSK plc has unveiled positive outcomes from the DREAMM-7 head-to-head phase III trial, evaluating Blenrep (belantamab mafodotin) as a treatment for relapsed or refractory multiple myeloma. This pivotal trial demonstrated a statistically significant progression-free survival (PFS) benefit for Blenrep combined with bortezomib and dexamethasone (BorDex) against the daratumumab plus BorDex regimen. Trial Details and Efficacy […]
Lunsumio FDA approval : Genentech, a subsidiary of the Roche Group, has secured the approval of the US Food and Drug Administration (FDA) for Lunsumio (mosunetuzumab-axgb) for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) in adults, subjected to two or more treatments for their cancer. Lunsumio is a CD20xCD3 T-cell engaging bispecific […]
Thermo Fisher Scientific has agreed to acquire The Binding Site Group, a UK-based specialist protein diagnostics company, for £2.25 billion ($2.6 billion) in an all-cash deal from a shareholder consortium led by Nordic Capital. The Binding Site Group offers specialty diagnostic assays and instruments to help in the diagnosis and management of immune system disorders […]
The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced the US Food and Drug Administration’s approval of its first bispecific T-cell engager antibody, TECVAYLI (teclistamab-cqyv). The medication is intended for the treatment of relapsed or refractory multiple myeloma patients. TECVAYLI is indicated for patients previously treated with a proteasome inhibitor, immunomodulatory drug, and […]
Bristol Myers Squibb (BMS) has secured priority review from the US Food and Drug Administration (FDA) for its supplemental biologics license application (sBLA) for Breyanzi (lisocabtagene maraleucel). The sBLA is for expanding the current indication of the CD19-directed chimeric antigen receptor (CAR) T cell therapy to be used in the treatment of relapsed or refractory […]
Protagonist Therapeutics has bagged the orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for PTG-300 for polycythemia vera treatment. Polycythemia vera is a type of blood cancer, which is mainly characterized by the increased production of red blood cells. According to the California-based biopharma company, PTG-300 is an injectable synthetic peptide […]
Cellectis said that it has dosed the first patient in a phase 1 study – the MELANI-01 clinical trial to evaluate UCARTCS1, an allogeneic off-the-shelf CAR-T product candidate for the treatment of relapsed/refractory multiple myeloma (R/R MM). The French gene therapy company began the phase 1 dose-escalation study after getting clearance from the US Food […]
The blood cancer drug for elderly patients, sapacitabine (CYC682) developed by New Jersey based Cyclacel Pharmaceuticals has failed to meet its objective in a crucial phase 3 study.
Cyclacel Pharmaceuticals, a New Jersey-based biopharmaceutical company, announced that its experimental blood cancer drug, sapacitabine (CYC682), did not meet the primary endpoint in the pivotal phase 3 SEAMLESS study. The trial aimed to evaluate the effectiveness of sapacitabine in elderly patients over 70 years old who are newly diagnosed with acute myeloid leukemia (AML) and […]
Pfizer Inc. has received a priority review designation from the U.S. Food and Drug Administration (FDA) for its innovative blood cancer drug, inotuzumab ozogamicin. This critical status will expedite the review process, potentially bringing this new treatment option to patients with acute lymphoblastic leukemia (ALL) sooner. FDA Priority Review Accelerates Approval Process Inotuzumab ozogamicin, an […]
