Berlin, CT (Press Release) – Breckenridge Pharma­ceu­tical, Inc. an­nounced to­day that the U.S. Food and Drug Admin­istra­tion has ap­prov­ed Breckenridge's Abbreviated New Drug Appli­ca­tion for Poma­lido­mide Capsules (generic for Pomalyst®).

Breckenridge has part­nered with Natco Pharma Limited for the de­vel­op­ment and manu­fac­ture of this prod­uct. According to in­dus­try sales data, Pomalyst had annual sales of $957 mil­lion during the twelve months ending Sep­tem­ber 2020. Celgene, Breckenridge and Natco have set­tled the U.S. district court lit­i­ga­tion with respect to this prod­uct.

About Breckenridge

Breckenridge Pharma­ceu­tical, Inc., a sub­sid­i­ary of Towa Pharma­ceu­tical (Osaka, Japan), part­ners …

Applications sup­ported by pos­i­tive re­sults from the Phase 3 APOLLO study, which dem­onstrated longer pro­gres­sion-free sur­vival in patients re­ceiv­ing the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab¹

RARITAN, N.J., Nov. 12, 2020 /PRNewswire/ -- The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the sub­mission of regu­la­tory appli­ca­tions to the U.S. Food and Drug Admin­istra­tion (FDA) and Euro­pean Medicines Agency (EMA) seek­ing ap­prov­al of the dara­tu­mu­mab sub­cu­tane­ous (SC) for­mu­la­tion, known as DAR­ZA­LEX FASPRO™ (dara­tu­mu­mab and hyal­uron­i­dase-fihj) in the U.S. and as DAR­ZA­LEX® SC in the Euro­pean Union (EU). The appli­ca­tions seek ap­prov­al of the com­bi­na­tion of DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (D-Pd) for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple …

• Phase 3 APOLLO ran­dom­ized study eval­u­ating sub­cu­tane­ous dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone versus poma­lido­mide and dexa­meth­a­sone alone in re­lapsed or re­frac­tory mul­ti­ple myeloma met the pri­mary end­point of im­prov­ing pro­gres­sion-free sur­vival
• Janssen in­tends to discuss the data with health author­i­ties for po­ten­tial regu­la­tory sub­missions

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the Euro­pean Myeloma Network (EMN) in col­lab­o­ration with Janssen Re­search & De­vel­op­ment, LLC (Janssen) re­ported pos­i­tive re­­sults from the Phase 3 APOLLO (MMY3013) study of the sub­cu­tane­ous (SC) for­mu­la­tion of dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (Pd) versus Pd alone as treat­ment for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have pre­vi­ously been treated with lena­lido­mide (an immuno­modu­la­tory drug) and a pro­te­a­some in­hib­i­tor (PI). The study met the pri­mary …

• Median pro­gres­sion-free sur­vival and over­all re­sponse rate doubled among patients re­ceiv­ing EPd com­pared to poma­lido­mide and low-dose dexa­meth­a­sone alone
• Second Empliciti-based com­bi­na­tion approved in Europe for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Com­mis­sion (EC) has approved Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory 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. This ap­prov­al is based on data from the ELOQUENT-3 trial in which EPd doubled both median pro­gres­sion-free sur­vival (PFS) and …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency has adopted a pos­i­tive opinion on a Type-II variation appli­ca­tion for Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory 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. The CHMP recom­men­da­tion will now be reviewed by the Euro­pean Com­mis­sion, …

POMALYST®, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, provides a new medication option for patients living with multiple myeloma

Toronto, ON (Press Release) – Celgene Inc. announced today that Health Canada has approved a POMALYST® (poma­lido­mide)-based triplet com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone. This is a new treat­ment option for patients with multiple myeloma (MM) who have received at least one prior treat­ment regi­men that in­cluded REVLIMID® (lena­lido­mide).

POMALYST® is an oral medication taken daily and is indicated, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of adult patients with MM who have received at least one prior treat­ment regi­men that in­cluded lena­lido­mide.^1,2

"The treat­ment landscape for multiple myeloma has sig­nif­i­cantly changed …

The European Com­mis­sion has approved two of Celgene’s IMiD®-based com­bi­na­tion regi­mens:

• 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), in adult patients with multiple myeloma, who have received at least one prior treat­ment regi­men in­­clud­ing REVLIMID.

Boudry, Switzerland (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Com­mis­sion (EC) has approved two new triplet regi­mens based on Celgene’s pro­pri­e­tary IMiD treat­ments, REVLIMID (lena­lido­mide) and IMNOVID (poma­lido­mide).

REVLIMID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (RVd), is now indicated for the treat­ment of adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant. In addi­tion, IMNOVID, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), is now indicated for the treat­ment of adult patients with multiple myeloma who have received at …