Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV today announced the sub­mission of a Type II variation appli­ca­tion to the European Medicines Agency (EMA), for the immuno­therapy DARZALEX®▼ (dara­tu­mu­mab). The appli­ca­tion seeks to broaden the existing mar­ket­ing authori­sa­tion to in­clude dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant.

“This sub­mission to health author­i­ties takes us one step closer to our goal of redefining com­bi­na­tion ther­apy in multiple myeloma, with the poten­tial to make dara­tu­mu­mab …

• Application to broaden label for dara­tu­mu­mab in front line multiple myeloma sub­mitted to EMA
• Submission based on data from Phase III ALCYONE study
• Genmab to receive USD 3 million in mile­stone pay­ments from Janssen

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation appli­ca­tion to the European Medicines Agency (EMA). This appli­ca­tion seeks to broaden the existing mar­ket­ing authori­za­tion for dara­tu­mu­mab (DARZALEX®) to in­clude use in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone, for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­el­i­gible for au­tol­o­gous stem cell trans­plant (ASCT). The sub­mission of the appli­ca­tion triggers mile­stone …

Toronto, Canada (Press Release) – Celgene Inc. announced today that Health Canada has expanded the indi­ca­tion for REVLIMID® (lena­lido­mide capsules), in multiple myeloma. REVLIMID® in com­bi­na­tion with dexa­meth­a­sone, is indicated for the treat­ment of multiple myeloma patients who are not eli­gible for stem cell trans­plant.¹ Nearly 60 per cent of newly diag­nosed people living with multiple myeloma are not eli­gible for a stem cell trans­plant,² so the expanded indi­ca­tion provides a new option for this patient pop­u­la­tion, where few existed before.

"The expanded indi­ca­tion of REVLIMID® provides patients with a treat­ment much earlier …

Amgen to Hold Analyst Call Today at 8:30 a.m. ET

Thousdand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced top-line results of the Phase 3 CLARION trial, which eval­u­ated an inves­ti­ga­tional regi­men of KYPROLIS® (car­filz­o­mib), mel­phalan and pred­ni­sone (KMP) versus Velcade® (bor­tez­o­mib), mel­phalan and pred­ni­sone (VMP) for 54 weeks in patients with newly diag­nosed multiple myeloma who were in­eli­gible for hema­to­poietic stem-cell trans­plant. The trial did not meet the pri­mary end­point of superiority in pro­gres­sion-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 per­cent CI, 0.75 - 1.10). While the data …

Boudry, Switzerland, and Tokyo (Press Release) – Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that REVLIMID^® (lena­lido­mide), a cancer medi­cine that is admin­istered orally, has been granted full market­ing authori­za­tion by Japan’s Ministry of Health, Labour and Welfare (MHLW) for use in com­bi­na­tion with dexa­meth­a­sone as a treat­ment for patients newly diag­nosed with multiple myeloma. This market­ing authori­za­tion expands upon the approval of REVLIMID in 2010 for the treat­ment of patients with re­lapsed or refractory multiple myeloma.

“The approval of REVLIMID as an option for use in …

Additional Presentation: Phase 2 Results From an Investigational study of Ixazomib plus Cyclophosphamide and Low-Dose Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma

Orlando, FL (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE:4502) today announced results from the TOURMALINE-MM1 trial presented at the 57^th Annual Meeting and Exposition of the American Society of Hematology (ASH), showing that treat­ment with NINLARO^® (ixazomib) capsules is effective in extending pro­gres­sion free survival (PFS) with a man­age­able tolerability profile in patients with re­lapsed and/or refractory multiple myeloma. The TOURMALINE-MM1 trial is an inter­na­tional, ran­dom­ized, double-blind, placebo-controlled Phase 3 clin­i­cal trial designed to eval­u­ate once-weekly oral ixazomib plus lena­lido­mide and dexa­meth­a­sone compared to placebo plus lena­lido­mide and dexa­meth­a­sone.

NINLARO …

A SWOG trial shows bor­tez­o­mib, lena­lido­mide, and dexa­meth­a­sone delays recurrence and lengthens life for myeloma patients, indicating a possible new standard of care

Portland, OR (Press Release) – The addi­tion of bor­tez­o­mib to a standard two‐drug regi­men for myeloma patients sig­nif­i­cantly lengthened the time before their cancer returned, and sig­nif­i­cantly lengthened their lives, according to new clin­i­cal trial results announced today.

The ran­dom­ized, phase III trial, conducted by SWOG, a publicly funded inter­na­tional cancer clin­i­cal trials network, compared the effectiveness of two drug regi­mens in patients undergoing their first round of treat­ment …