• Phase III POLLUX study of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone in patients with re­lapsed or refractory multiple myeloma met the pri­mary end­point at a pre-planned interim analysis
• Independent Data Monitoring Committee rec­om­mends unblinding the data
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the Phase III POLLUX study (MMY3003) of dara­tu­mu­mab in combi­na­tion with lena­lido­mide and dexa­meth­a­sone versus lena­lido­mide and dexa­meth­a­sone in patients with re­lapsed or refractory multiple myeloma met the pri­mary end­point of im­prov­ing pro­gres­sion free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.37 (95% CI 0.27-0.52), p < 0.0001). Patients who received treat­ment with dara­tumu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone had a 63% …

• Natco to Acquire License to Sell Generic Lena­lido­mide in the U.S. Without Volume Limitation commencing in late Jan­u­ary­, 2026
• License Will Also Provide Natco With a Volume-Limited Entry Beginning in March, 2022 with Anticipated Mid-Single-Digit Percentage Of Capsules Sold In the First 12 Months, Anticipated to Increase Gradually Each Year

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ: CELG) today announced the settle­ment of lit­i­ga­tion with Natco Pharma Ltd. of India, Natco’s U.S. partner, Arrow Inter­na­tional Limited, and Arrow’s parent com­pany, Watson Laboratories, Inc. (a wholly-owned sub­sid­i­ary of Allergan plc) relating to patents for REVLIMID^® (lena­lido­mide).

As part of the settlement, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Natco from mar­ket­ing generic lena­lido­mide before the expiration of the patents-in-suit, …

Boudry, Switzerland, and Tokyo (Press Release) – Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that REVLIMID^® (lena­lido­mide), a cancer medi­cine that is admin­istered orally, has been granted full market­ing authori­za­tion by Japan’s Ministry of Health, Labour and Welfare (MHLW) for use in com­bi­na­tion with dexa­meth­a­sone as a treat­ment for patients newly diag­nosed with multiple myeloma. This market­ing authori­za­tion expands upon the approval of REVLIMID in 2010 for the treat­ment of patients with re­lapsed or refractory multiple myeloma.

“The approval of REVLIMID as an option for use in …

Results featured at the 57th Annual American Society of Hematology Meeting and Exposition:

• 72 per­cent of re­lapsed or refractory multiple myeloma patients treated with dara­tu­mu­mab com­bi­na­tion ther­apy did not progress or relapse after 18 months of treat­ment (GEN 503)
• Daratumumab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone produced rapid, deep and durable responses in re­lapsed and refractory multiple myeloma patients who had received at least two (median of 3.5) prior lines of ther­apy, in­­clud­ing two or more consecutive cycles of lena­lido­mide and bor­tez­o­mib, and were refractory to their last line of treat­ment (MMY1001 Phase1b)
• Single-agent dara­tu­mu­mab dem­onstrated a median over­all survival of 20 months in heavily pre-treated re­lapsed and refractory multiple myeloma patients who have exhausted other approved treat­ment options. A partial response or better was achieved by 31 per­cent of patients, and 83 per­cent achieved stable disease or better (GEN 501 & MMY2002)

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced new data from the ongoing Phase 1/2 GEN503 inves­ti­ga­tional study showing the human CD38-directed mono­clonal anti­body dara­tumumab, in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, yielded an over­all response rate (ORR) of 81 per­cent in re­lapsed or refractory multiple myeloma patients who had received a median of two prior ther­a­pies. After 18 months of treat­ment, investigators observed an over­all survival (OS) rate of 90 per­cent, with 72 per­cent …

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG) today announced it has fulfilled the accelerated approval require­ments for POMALYST® (poma­lido­mide) based on results from MM-003, an inter­na­tional phase III study of POMALYST plus low-dose dex­a­meth­a­sone versus high-dose dex­a­meth­a­sone in re­lapsed / refractory multiple myeloma patients. POMALYST, in com­bi­na­tion with dex­a­meth­a­sone is ap­proved for patients with multiple myeloma 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 ther­apy.

"There remains a sig­nif­i­cant unmet need …

Oral REVLIMID is approved for treat­ment until disease pro­gres­sion

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) for the treat­ment of adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant.

The REVLIMID Marketing Authorisation has been updated to in­clude this new indi­ca­tion in multiple myeloma, build­ing upon the already approved indi­ca­tion of REVLIMID in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of multiple myeloma in adult patients who have received at least one prior ther­apy.

Multiple …

REVLIMID plus dexa­meth­a­sone is now approved as an option for use in all patients with multiple myeloma

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) in com­bi­na­tion with dexa­meth­a­sone to in­clude patients newly diag­nosed with multiple myeloma (NDMM). REVLIMID plus dexa­meth­a­sone was pre­vi­ously approved in June 2006 for use in multiple myeloma patients who have received at least one prior ther­apy.

"The approval of REVLIMID as an option for use in all patients with multiple myeloma rep­re­sents a new paradigm in the man­agement of this disease," said Kenneth Anderson, …