publication date: May. 27, 2016

Drugs and Targets

CHMP Issues Positive Opinion For Kyprolis in Multiple Myeloma 

 

The European Medicines Agency Committee for Medicinal Products for Human Use adopted a positive opinion to extend the indication for Kyprolis (carfilzomib) to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.

The CHMP positive opinion is based on data from the phase III head-to-head ENDEAVOR study in which patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved superior progression-free survival of 18.7 months compared to 9.4 months in those receiving Velcade (bortezomib) plus dexamethasone, (HR=0.53; 95% CI: 0.44,0.65 p<0.0001).

The most common adverse reactions that occurred in greater than 20 percent of patients in the Kyprolis arm were anemia, fatigue, diarrhea, thrombocytopenia, nausea, pyrexia, dyspnea, respiratory tract infection, cough and peripheral edema.

The European Commission previously granted marketing authorization for Kyprolis in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy based on results of the ASPIRE study in November 2015. FDA approved a supplemental New Drug Application based on the ENDEAVOR results in January 2016.

 

ProNAi Therapeutics, Inc. obtained an exclusive license from Carna Biosciences Inc. in Japan for worldwide rights to develop and commercialize AS-141, a small molecule kinase inhibitor targeting CDC7.

Under the terms of the agreement, ProNAi will pay Carna Biosciences an initial upfront … Continue reading 42-21 CHMP Issues Positive Opinion For Kyprolis in Multiple Myeloma

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