Articles tagged with: Immunomodulatory Agents
Press Releases»
- 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% …
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- 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, …
Press Releases»

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 …
Press Releases»
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 …
Press Releases»

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 …
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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 …
Press Releases»
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, …