The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.
The FDA approved Monjuvi for second-line diffuse large B-cell lymphoma. Though the drug has the same antigen target as approved CAR-T cell therapies, it is designed for patients unable to tolerate such intensive treatments.
In a recent interview, Esperion president and CEO, Sheldon Koenig talks about the reality of statin intolerance and his company’s expansion into new diseases
The deal, worth up to $2B in milestones and other other payments, involves the monoclonal antibody tafasitamab, for which MorphoSys recently submitted an FDA approval application.
The German biotech company said Monday it had applied for approval of tafasitamab in diffuse large B-cell lymphoma, which targets the same antigen as CAR-T, but would be for a population unable to tolerate the cell therapies.
The German drugmaker plans to submit its data package for FDA approval by the end of the year, with potential approval next year. The package will include a synthetic control arm comprising real-world data.
A spokesperson for the company noted that patients in the Phase II L-MIND trial of the CD19-targeting drug tafasitamab would be too old and frail to be candidates for CAR-T therapies.
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