All Evaluable Patients to Date See Evidence of an Objective Response; Treatment Combination Associated with Statistically Significant Upregulation of PD-L1

Calgary, AB (Press Release) – Oncolytics Biotech^® Inc. ("Oncolytics") (TSX:ONC) (NASDAQ: ONCY) today announced that Dr. D.W. Sborov and colleagues made a poster presentation at the 15th Inter­na­tional Myeloma Workshop (IMW). The poster presentation, entitled "Combination Carfilzomib and the Viral On­co­lytic Agent REOLYSIN^® in Patients with Relapsed Multiple Myeloma: A Pilot Study Investigating Viral Pro­lifer­a­tion," discloses initial findings from a pilot study (NCI-9603) in patients with re­lapsed or refractory multiple …

• CHMP grants accelerated assess­ment to dara­tu­mu­mab
• MAA submitted September 9 by Janssen based on data from Phase II study (Sirius MMY2002)

Copenhagen, Denmark (Press Release) – Genmab A/S (OMX: GEN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assess­ment to the Marketing Authorization Application (MAA) for dara­tu­mu­mab. The MAA is for dara­tu­mu­mab as a treat­ment for patients with re­lapsed and refractory multiple myeloma. The MAA was submitted to the EMA on September 9, 2015 by Janssen-Cilag Inter­na­tional NV. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive world­wide license to …

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 …

South San Francisco (Press Release) – Atara Biotherapeutics, Inc. (Nasdaq:ATRA), today announced that its col­lab­o­rating investigators at Memorial Sloan Kettering Cancer Center (MSK) presented clin­i­cal data on cyto­toxic T lym­pho­cytes (CTL) activated against Wilms' Tumor 1 (WT1-CTL) at the 15th Inter­na­tional Myeloma Workshop in Rome, Italy. The WT1-CTL prod­uct can­di­date targets cancers expressing the Wilms Tumor 1, or WT1, an­ti­gen. The data is derived from the treat­ment of patients with re­lapsed-refractory Multiple Myeloma (MM), in­­clud­ing Plasma Cell Leukemia (PCL), with WT1-CTL after allogeneic hematopoietic cell trans­plan­ta­tion (alloHCT). Dr. Guenther Koehne, MD, and …

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 …