Pfizer to discontinue development program for PF 07265803 for LMNA-related dilated cardiomyopathy.
Enhertu approved in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer
Enhertu approved in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer
Based on these results, the Phase III trial and further development of PF 07265803 will be discontinued. This decision is not based on safety concerns.
“This development confirms the complexity of advancing new treatments for rare cardiovascular diseases and the need to further increase knowledge in this space. We thank the patients, families, investigators and members of the advocacy community who contributed to this research,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “Although this outcome is disappointing, Pfizer remains committed to continuing our work to evolve the treatment paradigm for patients with rare cardiovascular diseases.”
Pfizer is communicating with worldwide regulatory authorities, investigators and community groups regarding the discontinuation. Under their investigator’s guidance, patients enrolled in the Phase III trial will stop study medication and complete any necessary follow-up evaluations. Detailed data from the REALM-DCM study will be presented at future medical meetings to help inform ongoing research.
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