Amgen (NASDAQ: AMGN) revealed that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a favorable opinion to extend the current indication for Kyprolis. That meant it can be included in treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have get a minimum of one prior therapy.
The company's EVP of R&D, Sean Harper, commented, "In the first ever comparative Phase 3 head-to-head study of two proteasome inhibitors in relapsed multiple myeloma, Kyprolis in combination with dexamethasone nearly doubled progression-free survival compared to a current standard of care regimen. We are pleased that the CHMP has recognized these robust data with a positive opinion, and we look forward to ensuring approval of this extended indication of Kyprolis."
Amgen said the CHMP positive opinion was based on data from the final stage head-to-head ENDEAVOR trial in which patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved superior progression-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving Velcade plus dexamethasone, (HR=0.53; 95 percent CI: 0.44,0.65 p<0.0001).
The company also indicated the most common adverse reactions that happened 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 drug maker said the CHMP positive opinion would now be reviewed by the European Commission (EC). The company believes that if granted, the marketing authorization would be extended to include Kyprolis in combination with dexamethasone in the 28 member countries of the European Union, as well as Iceland, Lichtenstein and Norway.
On Friday, the stock traded 0.59 percent higher.
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