Data from Once-Weekly CHAMPION Phase 1/2 Study Presented at ASCO

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the initiation of the ARROW trial, a global Phase 3 study eval­u­ating the benefit of Kyprolis® (car­filz­o­mib) for Injection ad­min­is­tered once-weekly with dexa­meth­a­sone versus the current U.S. Food and Drug Admin­istra­tion (FDA) approved twice-weekly admin­istra­tion schedule in patients with re­lapsed and refractory multiple myeloma who have received prior treat­ment with bor­tez­o­mib and an immuno­modu­la­tory agent (IMiD). The trial was ini­ti­ated based on results from the Phase 1/2 CHAMPION study, which were presented (abstract no. 8527) at the 51st Annual Meeting …

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 …

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 …

Silver Spring, MD (Press Release) – On February 23, 2015, the U.S. Food and Drug Admin­istra­tion (FDA) granted accelerated approval to panobinostat (FARYDAK capsules, Novartis Pharma­ceu­ticals) in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least two prior regi­mens, in­­clud­ing bor­tez­o­mib and an immuno­modu­la­tory agent. As a con­di­tion of this accelerated approval, FDA requires the sponsor to conduct a trial to verify and describe the clin­i­cal benefit of panobinostat for patients with multiple myeloma.

Panobinostat is a histone deacetylase inhibitor.

The approval was …

• Farydak, an HDAC inhibitor with epigenetic activity, approved in combination for patients who received at least two prior regimens including bortezomib and IMiD[1]
• Farydak prolonged median PFS benefit when used with bortezomib and dexamethasone combination versus combination alone (from 6 to 11 months)[1]
• Multiple myeloma is an incurable blood cancer and there is an urgent need for new treatments[2]
• Farydak is approved under FDA's accelerated approval program; regulatory applications are underway in the EU, Japan

 …

Silver Spring, MD (Press Release) - The U.S. Food and Drug Admin­istra­tion today approved Farydak (panobinostat) for the treat­ment of patients with multiple myeloma.

Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. According to the National Cancer Institute, approx­i­mately 21,700 Americans are diag­nosed with multiple myeloma and 10,710 die from the disease annually.

Primarily affecting older adults, multiple myeloma causes plasma cells to rapidly multiply and crowd out other healthy blood cells from the bone marrow. When …