Pfizer has won European Commission conditional marketing authorization for its Elrexfio drug in certain patients with relapsed or refractory multiple myeloma, an incurable blood cancer.
The New York drugmaker on Friday said the approval covers Elrexfio in adults who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody and have shown disease progression on the last therapy.
Pfizer in August won U.S. Food and Drug Administration accelerated approval of Elrexfio, which the company has previously said it believes has the potential to become the next standard of care for multiple myeloma, given its favorable clinical results and the fact that it is administered subcutaneously instead of intravenously.
Multiple myeloma is the second most common type of blood cancer, with more than 176,000 new cases diagnosed annually around the world, including more than 50,000 in Europe.
Jefferies analyst Akash Tewari has said he thinks Elrexfio could generate about $1 billion in sales in 2030.
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