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 …

Filing Based on Data From Phase 3 Head-To-Head ENDEAVOR Study

Relapsed Multiple Myeloma Patients Treated With Kyprolis in Study Lived Twice as Long Without Disease Worsening

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) today announced the sub­mission of a supple­mental New Drug Application (sNDA) to the U.S. Food and Drug Admin­istra­tion (FDA) for Kyprolis® (car­filz­o­mib) for Injection to seek an expanded indi­ca­tion for the treat­ment of patients with a form of blood cancer, re­lapsed multiple myeloma, who have received at least one prior ther­apy. Kyprolis cur­rently has accelerated approval in the U.S. for the treat­ment of patients with re­lapsed multiple myeloma as a mono­ther­a­py.

The sNDA is based on data from the global Phase 3 …

The annual meetings of the American Society of Clinical Oncology (ASCO) and the Euro­pean He­ma­tol­ogy Asso­ci­a­tion (EHA) took place earlier this month. The two meetings were attended by tens of thousands of physi­cians from around the world, and featured a myriad of oral pre­sen­ta­tions, posters, and e-abstracts summarizing the re­­sults of new on­col­ogy- and he­ma­tol­ogy-related re­search.

Included in the re­search pre­sented at the two meetings were more than 200 stud­ies discussing new mul­ti­ple myeloma-related findings.

In addi­tion to the two large meetings held earlier this month, the Inter­na­tion­al Myeloma Work­ing Group (IMWG) …

A poster session yesterday at the 2015 American Society of Clinical Oncology (ASCO) annual meeting was the venue for the first substantial dose of multiple myeloma-related presentations at the conference.

During the session, research results were made available for review by meeting attendees in the form of posters, each of which summarized the results of a single study. As is typically the case during such sessions, each poster was about two feet high by three or four feet in length. All posters were displayed throughout a large conference hall.

Most of the …

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 …

The 51st annual meeting of the American Society of Clinical Oncology (ASCO) started earlier to­day, May 29, and will go through June 2 in Chicago.

Approximately 30,000 physicians and re­searchers from all over the world are ex­pec­ted to attend the five-day meeting to discuss cur­rent re­search in cancer treat­ment and care.

During the meeting, there will be pre­sen­ta­tions about all types of cancer, in­clud­ing many pre­sen­ta­tions focused spe­cif­i­cally on mul­ti­ple myeloma. In fact, more than 90 myeloma-related stud­ies are scheduled to be pre­sented, in one form or another, in con­nec­tion with the …

The results of a small Phase 1/2 clinical trial suggest that a com­bi­na­tion of Farydak and high-dose Kyprolis is effective as a treat­ment for re­lapsed multiple myeloma.

Participants in the trial were heavily pretreated, having had a median of five pre­vi­ous myeloma ther­a­pies. More than 70 per­cent of the patients, however, had at least a partial re­sponse to the trial regi­men at the target doses established during the trial’s first phase. The esti­mated two-year over­all survival rate among the patients was 67 per­cent.

A response rate of more than 70 per­cent is …