The CHMP adopted two pos­i­tive opinions recommending European Com­mis­sion approval of:

• REVLIMID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (RVd) in adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant
• IMNOVID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), for adult patients with multiple myeloma, who have received at least one prior treat­ment regi­men in­­clud­ing lena­lido­mide

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted pos­i­tive opinions for two triplet regi­mens based on Celgene’s pro­pri­e­tary IMiD® medications, REVLIMID (lena­lido­mide) and IMNOVID (poma­lido­mide).

The CHMP recommended approval of an expanded indi­ca­tion of REVLIMID as com­bi­na­tion ther­apy with bor­tez­o­mib and dexa­meth­a­sone (RVd) for the treat­ment of adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant.

The committee also recommended approval …

• In the ELOQUENT-3 trial, treat­ment with Empliciti plus poma­lido­mide and dexa­meth­a­sone (EPd) doubled median pro­gres­sion-free sur­vival and over­all re­sponse rate versus poma­lido­mide and dexa­meth­a­sone (Pd)¹
• Low dis­con­tinu­a­tion rates due to adverse reac­tions were observed with both EPd and Pd alone¹
• Empliciti, when used in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone, can be admin­istered once monthly after first two cycles¹

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) approved Empliciti (elo­tuzu­mab) in­jec­tion for intra­venous use in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (EPd) for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.¹ In ELOQUENT-3, a ran­dom­ized, open-label, Phase 2 trial, EPd dem­onstrated ben­e­fit in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma, doubling both median pro­gres­sion-free sur­vival (PFS) …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Medicines Agency (EMA) has val­i­dated the Com­pany’s type II variation appli­ca­tion for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­cluding lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. Validation of the appli­ca­tion con­firms the sub­mission is com­plete and begins the EMA’s centralized review process.

“Given the need for new treat­ment …

Application based on re­­sults from Phase 2 ELOQUENT-3 study

Princeton, NJ (Press Release) - Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) ac­cepted its supple­mental Biologics License Appli­ca­tion (sBLA) for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of patients with re­lapsed / re­frac­tory mul­ti­ple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. The FDA granted the appli­ca­tion priority review with an action date of De­cem­ber 27, 2018.

“This file ac­ceptance is an im­por­tant step in BMS’s on­go­ing efforts to ad­vance …

This year’s American Society of Clinical Oncology (ASCO) annual meeting began last Friday and will run through tomorrow.

Multiple myeloma-related pre­sen­ta­tions have been taking place every day of the meeting. The main myeloma-related oral pre­sen­ta­tion session of the meeting, how­ever, took place on Friday. Research summarized during oral pre­sen­ta­tion sessions usually is par­tic­u­larly im­por­tant, either because the subject itself is im­por­tant, or because the results are based on sub­stan­tial amounts of evi­dence (for example, a sizable clin­i­cal trial).

Given the poten­tial importance of the re­search results pre­sented last Friday, The Beacon asked …

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 …

Hyderabad, India (Press Release) – Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched a generic version of poma­lido­mide 1 mg, 2 mg, and 4 mg capsules in India. Pomalidomide is sold by Celgene Inc., in the USA, under the brand name POMALYST®.

Pomalidomide is a thalido­mide analogue indicated, in com­bi­na­tion with dexa­meth­a­sone, for patients with multiple myeloma (a type of blood cancer) who have received at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some inhibitor and have dem­onstrated disease pro­gres­sion on or within 60 days of completion of the last …