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 …

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 …

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

The NDA sub­mission was based on the pivotal Phase 3 trial TOURMALINE-MM1, an inter­na­tional, ran­dom­ized, double-blind, placebo controlled clin­i­cal trial of 722 patients designed to eval­u­ate the superiority of ixazomib plus lena­lido­mide and dex­a­meth­a­sone over placebo plus lena­lido­mide and …

Submission of rolling BLA to US FDA for dara­tu­mu­mab in multiple myeloma com­pleted by Janssen Biotech, Inc.

Completion of sub­mission triggers USD 15 million mile­stone pay­ment to Genmab

Copenhagen, Denmark (Press Release) — Genmab A/S (OMX: GEN) announced its licensing partner Janssen Biotech, Inc. has com­pleted the rolling sub­mission of the Biologics License Application (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for dara­tu­mu­mab. The sub­mission is for dara­tu­mu­mab as a treat­ment for patients with multiple mye­lo­ma who have received at least three prior lines of ther­apy in­­clud­ing both a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD) or who are double refractory to a PI and an IMiD. In May, 2013, dara­tu­mu­mab was granted a Break­through Therapy …

• Farydak (panobinostat) combination improved PFS by 7.8 months for patients who received >=2 prior regimens including bortezomib and an IMiD[1]
• Farydak would be the first HDAC inhibitor with epigenetic activity to treat multiple myeloma[2],[3]
• CHMP positive opinion marks a key milestone toward panobinostat availability in the EU, aligning with recent US FDA approval

Basel, Switzerland (Press Release) – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion …

The FDA approval follows similar recognition for ImMucin from the EMA. This approval dem­onstrates the FDA's acknowledgement of an existing medical need for treat­ment of multiple myeloma and ImMucin's poten­tial in treating this type of cancer.

Ness Ziona, Israel (Press Release) – Vaxil Bio, (TASE: VAXL) a com­pany specializing in the devel­op­ment of immuno­therapy-based drugs, reports today that its lead prod­uct, ImMucin, has been granted an "orphan drug" desig­na­tion by the US Food and Drug Admin­istra­tion (FDA), for the treat­ment of multiple myeloma (MM).

ImMucin is an immuno­therapeutic treat­ment which educates the MM …