Shares of Oncopeptides AB dropped 35% Dec. 7 on the U.S. FDA’s request to withdraw marketing authorization of Pepaxto (melflufen), a drug that had gained accelerated approval in early 2021 for use in relapsed/refractory multiple myeloma. The move followed a negative advisory committee vote in September 2022 and is based on the outcome of the confirmatory phase III Ocean study.
Sana Biotechnology Inc. has outlined the status of its pipeline following a portfolio prioritization. The company remains on track to file an IND this year for SC-291, the company's HIP-modified, CD19-targeted allogeneic chimeric antigen receptor (CAR) T therapy, with initial clinical data expected next year.
As GSK plc pulls Blenrep (belantamab mafodotin) from the U.S. market, the biotech giant will watch a lot of revenue go with it. Only two weeks ago a phase III confirmatory study data for the already-approved multiple myeloma drug fell short of meeting requirements for the U.S. FDA’s accelerated approval regulations, so the agency asked GSK to take the drug off the market.
There are doubts about the future of GSK plc’s multiple myeloma drug Blenrep (belantamab mafodotin) after it failed to meet its goal of improving progression-free survival compared with standard chemotherapy in a confirmatory trial, placing its conditional approvals in the U.S. and Europe at risk.
At the end of September, C4 Therapeutics Inc. disclosed the U.S. FDA’s green light for the phase I/II trial with CFT-1946 in solid tumors, but the firm has piqued Wall Street’s interest more with another program due to face off with Bristol Myers Squibb Co. (BMS) in multiple myeloma (MM) and non-Hodgkin lymphoma (NHL).
The U.S. FDA cleared teclistamab from Janssen Pharmaceutical Cos. as the first bispecific antibody for treating patients with relapsed or refractory multiple myeloma (MM), joining other BCMA-targeted drugs, including an antibody-drug conjugate and CAR T therapies.
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) took up the matter of Oncopeptides AB’s long-storied multiple myeloma (MM) drug, Pepaxto (melphalan flufenamide), and briefing documents ahead of the meeting – which provided little cause for optimism – proved predictive of ODAC’s vote. Shares of Oncopeptides (Stockholm:ONCO) have dropped more than 64% over the past five days as investor jitters worsened.
Levena Biopharma Co. Ltd. and Sorrento Therapeutics Inc. have synthesized antibody-drug conjugates consisting of auristatin analogues covalently linked to monoclonal antibody targeting B-cell maturation protein (BCMA) through a linker.
There is still a percentage of patients with multiple myeloma (MM) who do not respond to initial therapy, and they are considered as refractory MM patients. There is a need for novel biomarkers of treatment response in refractory MM.
The crosstalk between immune cells and multiple myeloma (MM) cells is an important determinant of MM progression, but the mechanisms behind this have not been fully defined.
