Articles tagged with: Immunomodulatory Agents
Press Releases»
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 …
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- Dr. Reddy’s licensed to sell volume-limited amounts of generic lenalidomide in the U.S. beginning on a confidential date after the March 2022 date previously granted to Natco
- Dr. Reddy’s also licensed to sell generic lenalidomide in the U.S. without volume limitation beginning on January 31, 2026
- The earliest licensed entry of any generic lenalidomide in the U.S. continues to be March 2022, based on settlements reached
New York, NY (Press Release) – Bristol Myers Squibb (NYSE:BMY) today announced that its wholly owned subsidiary, Celgene, and Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, DRL) have settled their litigation related 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 DRL from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, …
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- 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 …
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New York, NY (Press Release) – Starton Therapeutics Inc. (“Starton” or the “Company”), a biotechnology company focused on transforming standard of care therapeutics, today announced that it has filed PCT (“Patent Cooperation Treaty”) and US Non-Provisional patent applications entitled “Continuous Delivery of Lenalidomide and Other Immunomodulatory Agents” on April 21, 2020 (PCT Application No. PCT/US20/29159 and U.S. Application No. 16/854,810).
The PCT application, filed with the PCT receiving office at the U.S. Patent & Trademark Office, allows Starton to file patent applications to seek protection for the methods disclosed therein in most major …
Press Releases»

New York, NY (Press Release) – Starton Therapeutics Inc. (“Starton” or the “Company”), a biotechnology company focused on transforming standard of care therapeutics, today announced the completion of a proof of concept study of multiple myeloma with lenalidomide using a model which emulates transdermal delivery. The results of the study demonstrate that a continuous subcutaneous (SC) delivery of lenalidomide is superior in terms of efficacy and equivalent in tolerability when compared to a standard once daily pulsatile dosing of Revlimid® (Celgene Corporation) in mice. The positive outcome provides a clear path for development …
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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 …
Press Releases»
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% …