A new review in Blood Cancer Discovery outlines a key regulatory decision by an FDA committee that greenlights a new biomarker endpoint for accelerated drug approval in multiple myeloma and could cut a decade off the drug development process.
Tag: minimal residual disease
MD Anderson and AmMax Bio announce agreements to advance development of AMB-066 in colorectal cancer patients with minimal residual disease
MD Anderson and AmMax Bio announced agreements to develop and advance AmMax’s AMB-066 monoclonal antibody therapy for colorectal cancer with minimal residual disease.
EMBARGOED: Dozens of Presentations Advance Multiple Myeloma Research at the 2024 American Society for Hematology (ASH) Meeting
Patients with multiple myeloma are living longer thanks to a host of new immunotherapies and targeted drugs. But there is still no cure for the disease. Physician-scientists at Sylvester Comprehensive Cancer Center are working to change that, and will present research findings at the 2024 annual meeting of the American Society of Hematology (ASH).
Montefiore Einstein’s Marina Konopleva Joins Break Through Cancer TeamLab in Fight Against Acute Myelogenous Leukemia
Marina Konopleva, M.D., Ph.D., director of the Leukemia Program and co-director of the Blood Cancer Institute at the National Cancer Institute-designated Montefiore Einstein Comprehensive Cancer Center (MECCC), has joined forces with Break Through Cancer, a collaborative medical research foundation that supports teams of scientists as they advance treatments for some of the world’s deadliest cancers. Dr. Konopleva will play a pivotal role in the Eradicating Minimal Residual Disease (MRD) in Acute Myelogenous Leukemia (AML) TeamLab.
Wren Laboratories Unveils Dynamic Executive Leadership Team and 2024 Commercial Strategy Overhaul
Wren Laboratories announced executive leadership for commercial operations and market expansion. Dr. Abdel Halim is appointed CEO and CSO. Troy Tremaine Appointed to CCO, Dr. Eva Szarek Head of Marketing, and Melissa Ferone director of quality. Expansion includes AI-driven mRNA liquid biopsy genomic assays for biopharma and diagnostics.
Recent FDA Committee Vote Could Speed Multiple Myeloma Drug Approval
An FDA committee voted unanimously last month to approve a new clinical endpoint, minimal residual disease, when evaluating proposed drugs to treat multiple myeloma. The 12-0 vote was based primarily on an analysis spearheaded by C. Ola Landgren, M.D., Ph.D., first author of a new paper published May 20 in the journal Blood.
FDA’s ODAC Rules Unanimously on a Faster Way to Approve Multiple Myeloma Therapies
An FDA advisory committee (ODAC) voted 12-0 today in favor of a major shift in how the agency evaluates new treatments for multiple myeloma. If approved by the FDA, the result will be faster approval of new treatments for multiple myeloma.