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 …

Oral REVLIMID is approved for treat­ment until disease pro­gres­sion

Boudry, Switzerland (Press Release) – Celgene Inter­na­tional Sàrl, a wholly owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ: CELG), today announced that the European Com­mis­sion (EC) has approved REVLIMID® (lena­lido­mide) for the treat­ment of adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant.

The REVLIMID Marketing Authorisation has been updated to in­clude this new indi­ca­tion in multiple myeloma, build­ing upon the already approved indi­ca­tion of REVLIMID in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of multiple myeloma in adult patients who have received at least one prior ther­apy.

Multiple …

REVLIMID plus dexa­meth­a­sone is now approved as an option for use in all patients with multiple myeloma

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has expanded the existing indi­ca­tion for REVLIMID® (lena­lido­mide) in com­bi­na­tion with dexa­meth­a­sone to in­clude patients newly diag­nosed with multiple myeloma (NDMM). REVLIMID plus dexa­meth­a­sone was pre­vi­ously approved in June 2006 for use in multiple myeloma patients who have received at least one prior ther­apy.

"The approval of REVLIMID as an option for use in all patients with multiple myeloma rep­re­sents a new paradigm in the man­agement of this disease," said Kenneth Anderson, …