Cambridge, MA (Press Release) – Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the U.S. Food and Drug Administration (FDA) has approved VELCADE® (bortezomib) for the retreatment of adult patients with multiple myeloma (MM) who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment. The labeling update includes dosing guidelines as well as safety and efficacy findings for the use of VELCADE as a single agent or VELCADE in combination with dexamethasone in patients …
Kyprolis Helped Patients Live 8.7 Months Longer Without Their Disease Worsening
Results to Form Basis of Regulatory Filings Beginning in 1H 2015
Thousand Oaks, California and South San Francisco, California (Press Release) Amgen (NASDAQ:AMGN) and its subsidiary, Onyx Pharmaceuticals, Inc., today announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) met its primary endpoint of progression-free survival (PFS). Patients treated with Kyprolis® (carfilzomib) for Injection in combination with Revlimid® (lenalidomide) and low-dose dexamethasone (KRd) lived significantly longer without their disease worsening (median 26.3 months) compared …
Six Data Presentations at the European Hematology Association's 19th Congress
Natick, Massachusetts (Press Release) - Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced initial Phase 1 data from patients with multiple myeloma treated with Karyopharm's lead selective inhibitor of nuclear export (SINE), Selinexor (KPT-330), in combination with "low-dose" (20 mg twice weekly) dexamethasone. Among eight patients, the best responses were one stringent complete response (sCR), three partial responses (PRs), two minor responses (MRs), one progressive disease and one non-evaluable. Accordingly, the clinical benefit response rate (sCR+PR+MR) is 75% and the overall response rate (sCR+PR) is 50%. These new results will be …
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New York (Press Release) - Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that data demonstrating SL-401 efficacy in multiple myeloma (MM) preclinical models will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting being held May 30-June 3, 2014 in Chicago, IL.
In collaboration with Stemline, experiments conducted at the Dana-Farber Cancer Institute, Boston, MA, by Drs. Dharminder Chauhan and Kenneth Anderson and their MM research team demonstrated that Stemline's clinical candidate SL-401 significantly decreased the viability of malignant cells by targeting neighboring plasmacytoid dendritic cells (pDCs) in the tumor …
Designation granted for investigational agent elotuzumab in combination with lenalidomide and dexamethasone for treatment of multiple myeloma in patients who have received one or more prior therapies
Princeton, NJ and North Chicago, IL (Press Release) – Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies. The designation is based on findings from a randomized Phase 2, open-label study that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated …
Rochester, MN (Press Release) – In a proof of principle clinical trial, Mayo Clinic researchers have demonstrated that virotherapy – destroying cancer with a virus that infects and kills cancer cells but spares normal tissues – can be effective against the deadly cancer multiple myeloma. The findings appear in the journal Mayo Clinic Proceedings.
Two patients in the study received a single intravenous dose of an engineered measles virus (MV-NIS) that is selectively toxic to myeloma plasma cells. Both patients responded, showing reduction of both bone marrow cancer and myeloma protein. One patient, …