The move into Phase III for giroctocogene fitelparvovec comes on the heels of BioMarin's surprise setback when the FDA demanded more proof of durability of its rival hemophilia A gene therapy Roctavian.
A couple of months after BioMarin Pharmaceutical Inc.’s rival drug Roctavian came unstuck with US regulators, Pfizer Inc. and Sangamo Therapeutics, Inc. have moved their investigational gene therapy for hemophilia A into late-stage studies.
The partners announced that the first participant had been dosed in the Phase III AFFINE trial of giroctocogene fitelparvovec in...
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US FDA approval of Niktimvo for third-line chronic GVHD, a competitor to Sanofi’s Rezurock, came less than two months ahead of anticipated approval of Syndax’s leukemia drug revumenib.
The company’s giroctocogene fitelparvovec, partnered with Sangamo, could compete with BioMarin’s hemophilia A gene therapy Roctavian, but longer-term data may be needed.
2seventy bio sold full rights to a hemophilia A program and in vivo gene editing technology to partner Novo Nordisk.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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