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On May 4, Pfizer announced its first quarter 2021 performance report.
When releasing its first-quarter results, Pfizer also disclosed the latest developments in a number of drugs.
In February of this year, Pfizer advanced elranatamab to a pivotal Phase 2 clinical trial, which is based on the 80% overall response rate data observed in the 20 patients treated in the Phase 1 clinical trial MagnetisMM-1.
The suspension was due to the discovery of 3 cases of peripheral neuropathy in the MagnetisMM-1 trial.
In its latest report last December, Pfizer did not mention cases of peripheral neuropathy.
Faced with its own BCMA safety issues, Pfizer suspended patient administration in key Phase 2 clinical trials and provided the FDA with more information on cases of peripheral neuropathy.
In addition to the elranatamab setback, Pfizer also disclosed the latest status of the DMD gene therapy fordadistrogene movaparvovec (PF-06939926).
The reason for this delay is that FDA requires Pfizer to answer questions about IND applications, including questions about its effectiveness analysis matrix.
Pfizer has already started patient administration in its phase 3 clinical trial and seems to be ready to surpass Sarepta.
In the first quarter of the pipeline update, Pfizer also cancelled two projects.
Reference source: Pfizer halts BCMA trial amid safety woes, hit by DMD delay