Pivotal Study Demonstrated Kyprolis® (Carfilzomib) in Combination With Standard of Care can Extend Time Patients Live Without Disease Progressing

BLINCYTO® (Blinatumomab) is First Bispecific T cell Engager (BiTE®) Antibody Construct to be Granted Positive CHMP Opinion

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions recommending market­ing authori­za­tion for:

Kyprolis^® (car­filz­o­mib) in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy, and

BLINCYTO^® (blina­tumo­mab) as a con­di­tional market­ing authori­za­tion for the treat­ment of adults with Philadelphia chromosome-negative (Ph-) re­lapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

"We are pleased to receive positive CHMP …

Application Based on Phase 3 Head-to-Head Trial Showing Superiority of Kyprolis and Dexamethasone Over Bortezomib Plus Dexamethasone

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Admin­istra­tion (FDA) has accepted for priority review the supple­mental New Drug Application (sNDA) of Kyprolis^® (car­filz­o­mib) for Injection for patients with re­lapsed multiple myeloma. The sNDA is designed to expand the current indi­ca­tion to in­clude Kyprolis in com­bi­na­tion with dex­a­meth­a­sone for patients who have received at least one prior ther­apy. The Prescription Drug User Fee Act (PDUFA) target action date is Jan. 22, 2016.

The FDA's acceptance of this new sNDA for Kyprolis follows the …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Priority Review status to the New Drug Application (NDA) for ixazomib, the first inves­ti­ga­tional oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and/or refractory multiple myeloma.

“We are encouraged that both the U.S. and European regu­la­tory bodies have determined that the ixazomib appli­ca­tions qualify for an expedited review, underscoring the importance of new treat­ment options for patients with re­lapsed / refractory multiple myeloma,” said Melody …

Hyderabad, India (Press Release) – Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) today announced that it has entered into a strategic col­lab­o­ration with Amgen – one of the world’s leading independent bio­technology com­pa­nies – to mar­ket and distribute three Amgen med­i­cines in India in the areas of on­col­ogy and cardiology. Under the terms of the col­lab­o­ration, Dr. Reddy’s shall per­form a full range of regu­la­tory and commercial services to seek approval and launch Kyprolis® (car­filz­o­mib), BLINCYTO® (blinatumomab) and Repatha™ (evolocumab) in India. The col­lab­o­ration leverages the capabilities of both com­pa­nies, combining three of Amgen’s inno­va­tive ther­a­pies …

The American Society of Clinical Oncology (ASCO) meeting in any given year is hit-or-miss as far as breaking research for multiple myeloma goes.

However, at ASCO 2015, there were no two views among myeloma experts. It was probably one of the most sig­nif­i­cant ASCO meetings as far as pre­senta­tions of abstracts that have the poten­tial to alter the land­scape of myeloma treat­ment in the near future.

There is no way to do justice to all the presentations at ASCO this year. However, I have tried to prepare a quiz to high­light …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Med­i­cines Agency (EMA) has granted an accelerated assess­ment to ixazomib, an inves­ti­ga­tional oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and /or refractory multiple myeloma. The EMA awards an accelerated assess­ment to those medicines deemed to be of major public health interest and, in particular, thera­peutic inno­va­t.

Takeda ex­pec­ts to submit a market­ing authori­za­tion appli­ca­tion for ixazomib in the European Union …

Approval Expands Kyprolis Indication

Patients Treated With Kyprolis in Combination With Standard of Care Lived 50 Percent Longer Without Disease Worsening Compared to Standard of Care Alone in Pivotal Study

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) approved the supple­mental New Drug Application (sNDA) for Kyprolis® (car­filz­o­mib) for Injection in com­bi­na­tion with Revlimid® (lena­lido­mide) and dexa­meth­a­sone (KRd) for the treat­ment of patients with multiple myeloma who have received one to three prior lines of ther­apy.

"The expanded indi­ca­tion of Kyprolis provides patients with re­lapsed multiple myeloma a new thera­peutic option, helping to address a real unmet need for this common blood cancer," said Sean E. Harper, M.D., exec­u­tive vice …