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 …

• Oral REVLIMID® is the first and only medicine licensed in Europe for use as post-autologous stem cell trans­plan­ta­tion main­te­nance ther­apy in multiple myeloma
• The new indi­ca­tion expands the avail­a­bil­ity of REVLIMID® across the disease con­tin­uum of multiple myeloma

Boudry, Switzerland (Press Release) – Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ: CELG), today announced that the European Com­mis­sion (EC) has approved REVLIMID® (lena­lido­mide) as mono­therapy for the main­te­nance treat­ment of adult patients with newly diag­nosed multiple myeloma who have undergone au­tol­o­gous stem cell trans­plan­ta­tion (ASCT). REVLIMID® is the first and only licensed main­te­nance treat­ment avail­able to these patients.

The REVLIMID® Marketing Authorisation has been updated to in­clude this new indi­ca­tion, which expands on the existing multiple myeloma indi­ca­tions as …

• REVLIMID is the first and only treat­ment approved for main­te­nance fol­low­ing auto-HSCT
• Updated data from two large, ran­domized, controlled studies dem­onstrated median pro­gres­sion-free survival (PFS) advantages of 3.8 and 1.9 years, re­spec­tive­ly, in favor of patients receiving REVLIMID compared to no main­te­nance
• Median over­all survival (OS) for patients receiving REVLIMID in each study was 9.3 years and 8.8 years, re­spec­tive­ly, compared to 7 and 7.3 years for no main­te­nance in a descriptive analysis (studies not powered for OS)
• Approval enables Celgene to provide patients with treat­ment options across the multiple myeloma spectrum

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has expanded the existing indi­ca­tion for REVLIMID (lena­lido­mide) 10 mg capsules to in­clude use for patients with multiple myeloma as main­te­nance ther­apy fol­low­ing au­tol­o­gous hema­to­poietic stem cell trans­plant (auto-HSCT). The expanded indi­ca­tion makes REVLIMID the first and only treat­ment to receive FDA approval for main­te­nance use fol­low­ing auto-HSCT.

“Autologous stem cell trans­plant after induction ther­apy is …

• REVLIMID® is the first and only medicine granted positive CHMP opinion for post-Autologous Stem Cell Transplantation (ASCT) main­te­nance ther­apy in MM
• The new indi­ca­tion expands the avail­a­bil­ity of REVLIMID® across the disease con­tin­uum of MM

Boudry, Switzerland (Press Release) – Celgene Inter­na­tional Sàrl, a wholly owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of REVLIMID® as mono­therapy for the main­te­nance treat­ment of adult patients with newly diag­nosed multiple myeloma (MM) who have undergone au­tol­o­gous stem cell trans­plan­ta­tion (ASCT). Once approved by the European Com­mis­sion, REVLIMID® will be the first and only licensed main­te­nance treat­ment avail­able to …

Toronto, Canada (Press Release) – Celgene Inc. announced today that Health Canada has expanded the indi­ca­tion for REVLIMID® (lena­lido­mide capsules), in multiple myeloma. REVLIMID® in com­bi­na­tion with dexa­meth­a­sone, is indicated for the treat­ment of multiple myeloma patients who are not eli­gible for stem cell trans­plant.¹ Nearly 60 per cent of newly diag­nosed people living with multiple myeloma are not eli­gible for a stem cell trans­plant,² so the expanded indi­ca­tion provides a new option for this patient pop­u­la­tion, where few existed before.

"The expanded indi­ca­tion of REVLIMID® provides patients with a treat­ment much earlier …