• Farydak (panobinostat) combination is approved in the EU for patients with multiple myeloma who received >=2 prior regimens including bortezomib and IMiD[1]
• In clinical trials, Farydak combination increased PFS by 7.8 months in patients who received >=2 prior regimens, including bortezomib and an IMiD[1]
• As the first HDAC inhibitor approved in the EU for multiple myeloma, Farydak may help reset key cell function in multiple myeloma through epigenetic activity[2]
• Farydak is approved in the US and Japan

 …

This ac­ceptance for review marks the first in the U.S. for a SLAMF7-directed immunostimulatory anti­body

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for priority review the Biologics License Appli­ca­tion (BLA) for Empliciti (elo­tuzu­mab), an inves­ti­ga­tional Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory anti­body, for the treat­ment of mul­ti­ple myeloma as com­bi­nation ther­apy in patients who have re­ceived one or more prior ther­a­pies. Empliciti was pre­vi­ously granted Break­through Therapy Desig­na­tion, which ac­cord­ing to the FDA, is in­tended to expedite the devel­op­ment and review of drugs for serious or life-threatening con­di­tions. The Euro­pean Medicines …

Earlier this week, Bristol-Myers Squibb an­nounced that it had filed an appli­ca­tion to have elotuzumab approved in Europe as a new treat­ment for mul­ti­ple mye­lo­ma patients who have re­ceived one or more prior ther­a­pies (see re­lated Bristol-Myers press re­lease).

An im­por­tant part of elotuzumab’s Euro­pean ap­prov­al appli­ca­tion will be ef­fi­cacy and safety data from a Phase 3 clin­i­cal trial known as ELOQUENT-2. These re­sults drew sig­nif­i­cant attention when they were pre­sented at this summer’s Amer­i­can Society of Clinical Oncology (ASCO) and Euro­pean Hema­tology Associ­a­tion …

Results from two clin­i­cal trials (ELOQUENT-2 & CA204-009), each combining Empliciti with a dif­fer­en­t standard of care regi­men in­cluded in the sub­mission

Empliciti is poised to be the first-in-class SLAMF7-directed immunostimulatory anti­body

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the Euro­pean Medicines Agency (EMA) val­i­dated for review the Marketing Authori­za­tion Appli­ca­tion (MAA) for Empliciti, an inves­ti­ga­tional Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory anti­body, for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy in adult patients who have re­ceived one or more prior ther­a­pies. The appli­ca­tion was granted ac­cel­er­ated assess­ment by the EMA’s Com­mit­tee for Medicinal Products for Human Use (CHMP).

“We be­lieve the CHMP’s ac­ceptance for an ac­cel­er­ated assess­ment reflects the need for a new treat­ment op­tion for …

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 …