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 …

Topline data from the ran­dom­ized Phase II GRIFFIN study in trans­plant eli­gible, newly diag­nosed patients with multiple myeloma treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone met the study’s pri­mary end­point with a higher per­cent­age of stringent com­plete response in the dara­tu­mu­mab arm as com­pared with patients who received lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone alone

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that topline data from the Phase II GRIFFIN (MMY2004) study of newly diag­nosed patients with multiple myeloma eli­gible for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plan­ta­tion (ASCT), who were treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone (VRd), met its pri­mary end­point, demonstrating a higher per­cent­age of stringent com­plete responses (sCR) than patients who received VRd alone. Specifically, the topline data showed that 42.4% of patients treated with dara­tu­mu­mab in com­bi­na­tion with VRd achieved a sCR, com­pared to 32.0% …

• U.S. FDA grants Priority Review for dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed patients with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant
• September 26, 2019 PDUFA date

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) granted a Priority Review for the supple­mental Biologics License Application (sBLA) for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) as treat­ment for patients newly diag­nosed with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen), in March 2019. Priority Review is a …

Ein Team von US-Forschern hat die Ergebnisse einer Untersuchung von Augenlidkomplikationen bei Patienten mit multiplem Myelom veröffentlicht, die mit Velcade oder Kyprolis behandelt wurden. Auf Grundlage ihrer Unter­suchungsergebnisse schlagen die Autoren der neuen Studie auch Leitlinien für die Prävention und das Management solcher Komplikationen vor.

Die Autoren berichten über eine Fallserie von 16 Patienten, die nach Be­ginn der Behandlung mit Velcade (Bortezomib) oder Kyprolis (Carfil­zomib) entweder Blepharitis oder ein Hagelkorn entwickelten.

Blepharitis ist der medizinische Begriff für chronische Entzündungen des Augenlids; ein Hagelkorn (Chalazion) ist eine Zyste im Augenlid, die durch eine …

A team of U.S. researchers has published the results of an in­ves­ti­ga­tion into eyelid-related com­pli­ca­tions in multiple myeloma patients receiving treat­ment with Velcade or Kyprolis. Drawing on the results of their in­ves­ti­ga­tion, the authors of the new study also propose guidelines for the prevention and man­agement of such com­pli­ca­tions.

The authors report on a case series of 16 patients who devel­oped either blepharitis or chalazia after starting treat­ment with Velcade (bor­tez­o­mib) or Kyprolis (car­filz­o­mib).

Blepharitis is the medical term for chronic inflammation of the eyelid, and a chalazion is a cyst in …

Results of a small Phase 2 trial conducted in Switzerland indicate that the HIV treat­ment nelfinavir, in com­bi­na­tion with Velcade and dexa­meth­a­sone, has promising activity in patients with ad­vanced, Velcade-resistant multiple myeloma.

All 34 patients in the Swiss trial had pre­vi­ously been treated with, and stopped responding to, Velcade. All study par­tic­i­pants also were pre­vi­ously treated with Revlimid (lena­lido­mide) and had a median of five over­all prior lines of treat­ment.

In this heavily pre­treated patient group, the com­bi­na­tion of nelfinavir, Velcade, and dexa­meth­a­sone nevertheless achieved at least a partial response in 65 …

Results of a recent Phase 2 clin­i­cal trial in Denmark raise questions about the future role of the antibiotic clarithro­mycin (Biaxin) in the treat­ment of multiple myeloma.

Previous research has suggested that adding clarithromycin to standard myeloma treat­ment regi­mens could im­prove treat­ment efficacy without a sig­nif­i­cant increase in side effects.

As a result, clarithromycin-containing regi­mens such as “BiRd” (Biaxin, Revlimid, and dexa­meth­a­sone) have been employed by some myeloma specialists to treat both newly diag­nosed and re­lapsed patients.

The recent Danish trial, however, found that adding clarithromycin to the com­bi­na­tion of Velcade (bor­tez­o­mib), …