Application Designed to Support Conversion of Accelerated to Full FDA Approval

Thousand Oaks, Calif., March 30, 2015 (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has accepted the supple­mental New Drug Application (sNDA) of Kyprolis® (car­filz­o­mib) for Injection for the treat­ment of patients with re­lapsed multiple myeloma who have received at least one prior ther­apy. The sNDA is designed to sup­port the conversion of accelerated approval to full approval and expand the current Kyprolis indi­ca­tion. As part of the acceptance, the FDA granted Kyprolis priority review with a Prescription Drug User Fee Act …

Initial results of a large, head-to-head clinical trial show that re­lapsed myeloma patients treated with high-dose Kyprolis and dex­a­meth­a­sone had twice the pro­gres­sion-free survival of re­lapsed patients treated with Velcade and dex­a­meth­a­sone.

Median pro­gres­sion-free survival in the Phase 3 trial was 18.7 months in trial participants treated with high-dose Kyprolis (car­filz­o­mib) and dex­a­meth­a­sone (Decadron), compared to 9.4 months in patients treated with Velcade (bor­tez­o­mib) and dex­a­meth­a­sone.

The results of the so-called “ENDEAVOR” trial were announced this past Sunday evening in a press release issued by Amgen …

Study Met Primary Endpoint of Progression-Free Survival
Patients Receiving Kyprolis Lived Twice as Long Without Disease Progression

Thousand Oaks, CA and South San Francisco, CA (Press Release) – Amgen (NASDAQ: AMGN) and its sub­sid­i­ary Onyx Pharma­ceu­ticals, Inc., today announced the results from a planned interim analysis showing that the Phase 3 head-to-head clin­i­cal trial ENDEAVOR eval­u­ating Kyprolis® (car­filz­o­mib) for Injection in com­bi­na­tion with low-dose dexa­meth­a­sone versus Velcade® (bor­tez­o­mib) and low-dose dexa­meth­a­sone met the pri­mary end­point of pro­gres­sion-free survival (PFS). Patients with re­lapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clin­i­cally sig­nif­i­cant superiority over Velcade (median PFS 18.7 …

Thousand Oaks, CA and South San Francisco, CA (Press Release) – Amgen (NASDAQ: AMGN) and its sub­sid­i­ary Onyx Pharma­ceu­ticals, Inc., today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) of Kyprolis® (car­filz­o­mib) for Injection for the treat­ment of patients with re­lapsed multiple myeloma who have received at least one prior ther­apy. The MAA has been granted accelerated assess­ment by the EMA.

Kyprolis is a pro­te­a­some inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting ap­prox­i­mate­ly 89,000 people in …

A new year is upon us.  I hope it has started well for everybody, and that all had a great holiday season!

The last few weeks of 2014 were a hap­pen­ing time for the mul­ti­ple myeloma com­munity. The short span of time witnessed the pub­li­ca­tion of up­dated criteria for the diag­nosis of mul­ti­ple myeloma from the Inter­na­tional Myeloma Work­ing Group (IMWG). In addi­tion, the 56^th annual meeting of the American Society of He­ma­tol­ogy (ASH) took place in San Francisco, with literally hundreds of myeloma-related oral and poster pre­sen­ta­tions.

Therefore, it is again …

US Submission Designed to Support Conversion From Accelerated to Full FDA Approval and Expansion of Current Approved Indication
EMA Grants Kyprolis Accelerated Assessment and Orphan Drug Desig­na­tion

Thousand Oaks, CA and South San Francisco, CA (Press Release) – Amgen (NASDAQ:AMGN) and its sub­sid­i­ary Onyx Pharma­ceu­ticals, Inc., today announced the sub­mission of a supple­mental New Drug Application (sNDA) to the U.S. Food and Drug Admin­istra­tion (FDA) and a Marketing Authorization Ap­pli­cation (MAA) to the European Medicines Agency (EMA) for Kyprolis® (car­filz­o­mib) for Injection to seek approval for the treat­ment of patients with re­lapsed multiple myeloma who have received at least one prior ther­apy. In the U.S., the sNDA is designed to sup­port the conversion of accelerated approval …

This past Sunday was the second day of the American Society of Hema­tology’s (ASH) annual meeting, which was held in San Francisco.

As on the first day of the meeting, myeloma-related pre­sen­ta­tions once again took place during several sessions through­out the day.

A myeloma-related education session held the first day of the conference was repeated once again on Sunday morning.

While the education session was being held, a separate “scientific sym­po­sium” with two oral pre­sen­ta­tions took place in parallel.  The session focused on a novel immuno­therapeutic ap­proach to treating cancer known as …