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Pfizer's Elranatamab Gets Breakthrough Therapy Designation From FDA For R/R Multiple Myeloma

Pfizer Inc. (PFE) said that its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of people with relapsed or refractory multiple myeloma or RRMM.

Elranatamab is a B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb).

The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of a medicine that is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies.

In addition to the Breakthrough Therapy Designation, elranatamab has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for the treatment of Multiple Myeloma or MM.

The FDA and EMA have granted elranatamab Fast Track Designation and the PRIME scheme, respectively, for the treatment of patients with RRMM. The UK Medicines and Healthcare Products Regulatory Agency has also granted elranatamab Innovative Medicine Designation and the Innovation Passport, for the treatment of MM.

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