FDA Issues Guidance on the Use of Plasma Fibrinogen Biomarker
The agency provides a qualified context of use for the biomarker plasma fibrinogen.
On Sept. 14, 2016, FDA published guidance providing a qualified context of use (COU) for plasma fibrinogen, a biomarker, in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high risk for exacerbations and/or all-cause mortality. According to FDA, “fibrinogen is an acute phase protein that is elevated in inflammation. It is a soluble plasma glycoprotein that is converted by thrombin to fibrin during blood clot formation.”
The experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research’s (CDER) Biomarker Qualification Program are also described. The guidance states that drug developers may use plasma fibrinogen “for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.” FDA states that the use of the biomarker outside of the qualified COU will be considered on a case-by-case basis and more information regarding the expanded use may be required.
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
