Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its re­quest for an accelerated assess­ment of the dara­tu­mu­mab Marketing Authorisation Application (MAA). This acceptance follows the earlier regu­la­tory sub­mission of a MAA which seeks authori­sa­tion of dara­tu­mu­mab as a single agent for the treat­ment of patients with re­lapsed and refractory multiple myeloma and is cur­rently pend­ing val­i­da­tion by the EMA.

The CHMP grants accelerated assess­ment when a medicinal prod­uct is ex­pec­ted to be …

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 …

New Treatment Combination with CTL019 Targets Precursors of Cancerous White Blood Cells

Philadelphia (Press Release) – A multiple myeloma patient whose cancer had stopped responding after nine dif­fer­en­t treat­ment regi­mens ex­peri­enced a com­plete remission after receiving an inves­ti­ga­tional per­son­al­ized cellular ther­apy known as CTL019 developed by a team at the University of Pennsylvania. The inves­ti­ga­tional treat­ment was com­bined with chemo­ther­apy and an au­tol­o­gous stem cell trans­plant – a new strat­egy designed to target and kill the cells that give rise to myeloma cells.

The team’s findings are published in a case report …

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 …

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced today it has submitted a new Marketing Authorisation Application to the European Medicines Agency (EMA) for dara­tu­mu­mab, an in­ves­ti­ga­tional, human anti-CD38 mono­clonal anti­body, for the treat­ment of patients with re­lapsed and refractory multiple myeloma.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is char­ac­ter­ised by excess growth and survival of malignant plasma cells.^[1] Patients who are refractory to both pro­te­a­some inhibitors (PIs) or immuno­modu­la­tory agents (IMiDs) have a poor prognosis, with an esti­mated median over­all survival of …

If approved, dara­tu­mu­mab will offer a new option for double refractory, heavily pre-treated patients

Raritan, NJ (Press Release) – Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Admin­istra­tion (FDA) has accepted for Priority Review the Biologics License Application (BLA) for dara­tu­mu­mab as a treat­ment for patients with multiple myeloma who are refractory to both a pro­tea­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who have received three or more prior lines of ther­apy, in­­clud­ing a PI and an IMiD. This is referred to as "double refractory" multiple myeloma, which occurs when a patient's disease has be­come resistant to at least …

• U.S. FDA grants Priority Review to dara­tu­mu­mab
• PDUFA target date has been set to March 9, 2016

Copenhagen (Press Release) – Genmab A/S (OMX: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Priority Review to the Biologics License Application (BLA) for dara­tu­mu­mab. The BLA is for dara­tu­mu­mab as a treat­ment for patients with multiple myeloma who have received at least three dif­fer­en­t lines of ther­apy in­­clud­ing both a pro­te­a­some inhibitor and an immuno­modu­la­tory agent (IMiD) or who are double refractory to a pro­te­a­some inhibitor and an IMiD. A rolling BLA sub­mission was started by Genmab’s …