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Amgen Submits Application In Europe To Expand Indication Of Kyprolis® (carfilzomib) For The Treatment Of Relapsed Multiple Myeloma

Application Based on Pivotal Head-to-Head ENDEAVOR Study Showing Kyprolis Plus Dexamethasone Doubled Progression-Free Survival Compared to Velcade® (Bortezomib) Plus Dexamethasone

THOUSAND OAKS, Calif., Dec. 5, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission to the European Medicines Agency (EMA) of a Variation to the Marketing Authorization Application (MAA) to expand the indication for Kyprolis® (carfilzomib) in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

The application is based on results from the Phase 3 head-to-head ENDEAVOR study in which patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved superior progression-free survival (PFS) compared to those receiving Velcade® (bortezomib) plus dexamethasone (18.7 versus 9.4 months, respectively) (p<0.0001). The most common adverse events (greater than 25 percent) in the Kyprolis arm were diarrhea, anemia, fatigue, dyspnea, pyrexia and insomnia.

"Physicians need options to personalize treatment for complicated diseases like multiple myeloma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to continued discussions with health authorities with the goal of bringing new Kyprolis-based regimens to patients in Europe."

The European Commission (EC) recently granted marketing authorization following accelerated assessment 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.
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Source: press release, 12/05/15. http://wwwext.amgen.com/media/news-releases/2015/12/amgen-submits-applic...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Kyprolis (Carfilzomib)Oncology HematologicMultiple Myeloma20S proteasome inhibitor20S proteasome

Mechanism of action: Kyprolis (Carfilzomib) irreversibly binds to and inhibits the chymotrypsin-like activity of the 20S proteasome, an enzyme responsible for degrading a large variety of cellular proteins. Inhibition of proteasome-mediated proteolysis results in an accumulation of polyubiquinated proteins, which may lead to cell cycle arrest, induction of apoptosis, and inhibition of tumor growth.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-06-24

Results:

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Amgen Receives Positive CHMP Opinion To Extend Indication Of Kyprolis® (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma
Pivotal Head-to-Head ENDEAVOR Study Shows Kyprolis Plus Dexamethasone Doubled Progression-Free Survival Compared to Velcade® (Bortezomib) and Dexamethasone
THOUSAND OAKS, Calif., May 27, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current 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.

"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," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "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."

The CHMP positive opinion is based on data from the Phase 3 head-to-head ENDEAVOR study 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® (bortezomib) plus dexamethasone, (HR=0.53; 95 percent 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 CHMP positive opinion will now be reviewed by the European Commission (EC) and if granted, the marketing authorization will 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. The extended indication adopted by the CHMP is: Kyprolis in combination with either lenalidomide and dexamethasone or dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

The EC 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. Today's CHMP positive opinion follows the U.S. Food and Drug Administration's approval of a supplemental New Drug Application based on the ENDEAVOR results in January 2016.
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Source: press release, 5/27/16. http://wwwext.amgen.com/media/news-releases/2016/05/amgen-receives-posit...

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