Princeton, NJ (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has placed a partial clin­i­cal hold on CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142, three clin­i­cal trials in­vesti­gating Opdivo (nivolumab)-based com­bi­na­tions in patients with re­lapsed or refractory multiple myeloma.

This partial clin­i­cal hold is related to risks identified in trials studying another anti–PD-1 agent, pem­bro­lizu­mab, in patients with multiple myeloma. The FDA determined data cur­rently avail­able from non-Opdivo studies indicate the risks of PD-1/PD-L1 treat­ment plus poma­lido­mide or lena­lido­mide and possibly PD-1/PD-L1 treat­ments alone or with other com­bi­na­tions outweigh poten­tial benefit for …

Silver Spring, MD (Press Release) – Based on data from two recently halted clin­i­cal trials, the U.S. Food and Drug Admin­istra­tion today is issuing this state­ment to inform the public, health care professionals, and on­col­ogy clin­i­cal investigators about the risks asso­ci­ated with the use of KEYTRUDA® (pem­bro­lizu­mab) in com­bi­na­tion with dexa­meth­a­sone and an immuno­modu­la­tory agent (lena­lido­mide or poma­lido­mide) for the treat­ment of patients with multiple myeloma. KEYTRUDA® (pem­bro­lizu­mab) is not approved for treat­ment of multiple myeloma.

The FDA state­ment is based on review of data from two clin­i­cal trials (KEYNOTE-183 and KEYNOTE-185) eval­u­ating …

Madison, WI (Press Release) – Cellectar Biosciences, Inc. (Nasdaq:CLRB), an on­col­ogy-focused, clin­i­cal stage bio­technology com­pany (the "company"), to­day an­nounces its lead PDC com­­pound, CLR 131 has achieved a median over­all sur­vival of 22.5 months to date after a single dose in­fusion of 12.5mCi/m² in patients with mul­ti­ple myeloma. Patients in the first cohort of the com­pany's Phase 1 clin­i­cal trial had an average of 5.8 prior lines of treat­ment and there­fore were con­sidered to be heavily pre­treated.

It is im­por­tant to note that the trial remains on­go­ing, and the over­all sur­vival could con­tinue …

Kenilworth, NJ (Press Release) – Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has placed a clin­i­cal hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combi­na­tion studies of KEYTRUDA® (pembro­lizu­mab), the com­pany’s anti-PD-1 ther­apy, in the blood cancer multiple myeloma. This de­ci­sion follows a review of data by the Data Monitor­ing Committee in which more deaths were observed in the KEYTRUDA arms of KEYNOTE-183 and KEYNOTE-185 and which led to the pause in new patient enroll­ment, as announced on June 12, …

FDA Sets PDUFA Target Action Date of Feb. 3, 2018

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has accepted the XGEVA® (denosumab) supple­mental Biologics License Appli­ca­tion (sBLA) that seeks to expand the cur­rently approved indi­ca­tion for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to in­clude patients with multiple myeloma. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Feb. 3, 2018.

"Multiple myeloma patients with fractures and other bone com­pli­ca­tions have a very poor prognosis. …

DARZALEX com­bi­na­tion ther­apy offers a new option for patients pre­vi­ously treated with two commonly used treat­ments (lena­lido­mide and a pro­te­a­some inhibitor)

Horsham, PA (Press Release) – Janssen Biotech, Inc. announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the immuno­therapy DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least two prior ther­a­pies in­­clud­ing lena­lido­mide (an immuno­modu­la­tory agent) and a pro­te­a­some inhibitor (PI).¹ Clinical trial results showed an over­all response rate (ORR) of 59.2 per­cent with DARZALEX in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone in these patients.¹

DARZALEX is the first CD38-directed anti­body approved any­where in the world.² It was …

Kenilworth, NJ (Press Release) – Merck (NYSE:MRK), known as MSD outside the United States and Canada, today provided an update on two com­bi­na­tion studies of KEYTRUDA® (pem­bro­lizu­mab), the com­pany’s anti-PD-1 ther­apy, in the blood cancer multiple myeloma. Merck has accepted the external Data Monitoring Committee recom­men­da­tion to pause new enrollment on KEYNOTE-183 and KEYNOTE-185, two studies exploring KEYTRUDA treat­ment in com­bi­na­tion with other ther­a­pies in multiple myeloma. The pause is to allow for addi­tional in­­for­ma­tion to be collected to better under­stand more reports of death in the KEYTRUDA groups. Patients cur­rently enrolled in …