Multiple Myeloma
Mar 12, 2024
BeiGene’s BRUKINSA Gets FDA Accelerated Approval; GSK’s Positive Results in DREAMM-8 Phase III; Sandoz’s Denosumab Biosimilars FDA Approved; Terns Pharma’s TERN-701 Receives Orphan Drug Designation; Wegovy® Approved in US for Overweight Cardiovascular Risk; Travere Therapeutics Submits sNDA for FILSPARI IgAN Full Approval
BeiGene Receives FDA Accelerated Approval for BRUKINSA in Relapsed/Refractory Follicular Lymphoma BeiGene, Ltd., has declared that the FDA has provided accelerated approval for BRUKINSA® (zanubrutinib) to be used in treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), when used alo...
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Jan 30, 2024
Merck’s KEYTRUDA as Adjuvant Therapy for RCC Patients; BMS Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma for Multiple Myeloma; FDA Approves Dupixent for Eosinophilic Esophagitis; Juvena Receives FDA Orphan Drug Designation for JUV-161; European Commission Authorizes GSK’s Omjjara; ENHERTU Granted Priority Review in the US for for metastatic HER2-positive Solid Tumors
Merck’s KEYTRUDA Reduced the Risk of Death by 38% Versus Placebo as Adjuvant Therapy for Patients With Renal Cell Cancer (RCC) at an Increased Risk of Recurrence Following Nephrectomy Merck, also known as MSD beyond the United States and Canada, has revealed findings from the Phase III KEYNOTE-564 trial, which a...
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Dec 14, 2023
TALVEY’s Versatility Shines: Key Insights from MonumenTAL-2 Study Illuminate Effective Strategies in Relapsed/Refractory Multiple Myeloma
Date of Abstract presentation11th December 2023IndicationsMultiple MyelomaAbstract Number1014Abstract typeOral TALVEY (talquetamab) is a bispecific T-cell engaging antibody designed to target the CD3 receptor found on T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D). The findings presente...
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Dec 13, 2023
DARZALEX FASPRO Quadruplet Regimen Demonstrates Striking Advancements in Treatment Outcomes for Newly Diagnosed Multiple Myeloma Eligible for Transplantation
Date of Abstract presentation12th December 2023IndicationsMultiple MyelomaAbstract NumberLBA1Abstract typeOral The PERSEUS study is being conducted in collaboration with the European Myeloma Network as a sponsor. PERSEUS is an ongoing, randomized, open-label, Phase III study comparing the efficacy and safety of ...
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Dec 13, 2023
Cilta-cel Demonstrates Prolonged and Deep Responses across Advanced Treatment Lines, Signifying Potential in Early Lenalidomide-Refractory Multiple Myeloma
Date of Abstract presentation11th December 2023IndicationsMultiple MyelomaAbstract Number1063Abstract typeOral According to the findings presented at the ASH 2023, the CARTITUDE-4 trial included a cohort of 419 patients. As of the clinical cut-off, 99 patients in the CARVYKTI arm and 66 in the standard of care (...
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Dec 13, 2023
Cilta-Cel’s Prolonged Impact: Deep Responses and Safety Insights from Earlier Lines of Therapy in Multiple Myeloma
Date of Abstract presentation11th December 2023IndicationsMultiple MyelomaAbstract Number1021Abstract typeOral CARVYKTI (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s T cells with a transge...
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Oct 03, 2023
AbbVie Presents Phase III CANOVA Study Results; Novartis’ Iptacopan Shows Promise in Phase III Study; Fast Track Designation to AVB-001 for R/R Platinum-Resistant Ovarian Cancer; FDA Issues Complete Response Letter for Lebrikizumab; Nedosiran Approveed for Primary Hyperoxaluria Type 1; Orphan Drug Designation to BDC-1001 for Gastric Cancers
AbbVie Presents Results from Phase III CANOVA Study of Venetoclax in Patients with Relapsed or Refractory Multiple Myeloma AbbVie has released findings from its Phase III CANOVA trial, which assessed the safety and effectiveness of venetoclax (marketed as VENCLEXTA®/VENCLYXTO®) in combination with dexamethasone ...
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Aug 29, 2023
FDA Approves BMS’s Reblozyl for MDS; FDA Awards Orphan Drug Designation to NXC-201; Janssen Submits Supplemental NDA for Full Approval of BALVERSA; FDA Grants Fast Track Status to ALE.C04; FDA Orphan Drug Designation to Faron’s Bexmarilimab; FDA Clears IND Application for AHB-137
FDA Approves Bristol Myers Squibb’s Reblozyl as First-Line Treatment of Anemia in Adults with Lower-Risk MDS Who May Require Transfusions Bristol Myers Squibb announced that the Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt) for the treatment of anemia in adult patients with very l...
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Aug 15, 2023
J&J’s 2-in-1 Tablet for Prostate Cancer; FDA Approves TALVEY for Heavily Pretreated Multiple Myeloma; PDS Biotech Updated on VERSATILE-003 Trial; FDA Issues CRL to NDA for Avasopasem in Radiotherapy-Induced Severe Oral Mucositis in HNC; FDA Orphan Drug Designation to Genprex’s REQORSA; FDA Orphan Drug Designation to Bloomsbury’s BGT-OTCD
FDA Clears J&J’s 2-in-1 Tablet for Prostate Cancer Johnson & Johnson's Janssen Pharmaceutical Companies stated that the US Food and Drug Administration (FDA) had approved AKEEGA (niraparib and abiraterone acetate), the first-and-only dual-action tablet combining a PARP inhibitor including abiraterone ace...
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Feb 27, 2023
Minimal Residual Disease (MRD) Testing: A Path to Cure Cancer?
Measurable or Minimal Residual Disease (MRD) is a term often used when treating patients with blood cancers. MRD is a small number of cancer cells left in the body after cancer treatment, and these cells can potentially cause relapse in these patients. The number of remaining cells is often too small to cause any s...
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