FDA ’s ODAC Votes 12 to 0 That MRD Is a Viable End Point in Myeloma Trials
In a 12 to 0 vote, the FDA’s Oncologic Drugs Advisory Committee (ODAC) decided that evidence supported that minimal residual disease (MRD) could be used as an accelerated approval end point in clinical trials of multiple myeloma. “I think the sets a precedence of actually moving the field forward,…#fda #odac #mrd #ranjanahadvani #saulrosenberg #nicolegormley #approval #bindukanapuru #kanapuru #colalandgren (Source: Reuters: Health)
Source: Reuters: Health - April 13, 2024 Category: Consumer Health News Source Type: news

FDA Approves Abecma for Relapsed, Refractory Multiple Myeloma
TUESDAY, April 9, 2024 -- The U.S. Food and Drug Administration has approved Abecma (idecabtagene vicleucel) as a personalized CAR T-cell therapy for triple-class exposed relapsed or refractory multiple myeloma.The approval is for the treatment of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 9, 2024 Category: Pharmaceuticals Source Type: news

How to Deal With Side Effects of Multiple Myeloma Treatment
Diagnosed with multiple myeloma? WebMD shows how you can conquer treatment-related side effects. (Source: WebMD Health)
Source: WebMD Health - April 9, 2024 Category: Consumer Health News Source Type: news

FDA Approves Earlier Use of CAR-T Products for Myeloma
(MedPage Today) -- The FDA expanded the labels of two CAR T-cell products for multiple myeloma, allowing their use in earlier lines of treatment for relapsed or refractory disease. Ciltacabtagene autoleucel (cilta-cel; Carvykti) is now approved... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - April 9, 2024 Category: American Health Source Type: news

High Response Rate in R/R Multiple Myeloma With Bispecific Antibody
(MedPage Today) -- SAN DIEGO -- More than 70% of patients with heavily pretreated multiple myeloma responded to an investigational bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, results from a prospective trial showed... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - April 8, 2024 Category: Hematology Source Type: news

Abecma Approved for Earlier Lines in R/R Multiple Myeloma Abecma Approved for Earlier Lines in R/R Multiple Myeloma
The drug manufacturers report a complete response rate of 39% with idecabtagene vicleucel (Abecma) vs 5% with standard regimens.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - April 8, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology Source Type: news

FDA Approves Carvykti for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy
HORSHAM, PA (April 5, 2024)– Johnson& Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved Carvykti® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 5, 2024 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
PRINCETON, N.J.,& CAMBRIDGE, Mass.--(BUSINESS WIRE) April 05, 2024 -- Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 5, 2024 Category: Drugs & Pharmacology Source Type: news

Model Predicts Need for Bone Marrow Sampling in Monoclonal Gammopathy of Undetermined Significance
MONDAY, April 1, 2024 -- A recently developed multivariable model can accurately predict smoldering multiple myeloma (SMM) or worse in persons with presumed monoclonal gammopathy of undetermined significance (MGUS), according to a study published... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 1, 2024 Category: Pharmaceuticals Source Type: news

‘This person saved her’: the cancer patients in need of a stem cell donor match
Four in 10 UK patients do not find a match and those from non-white backgrounds find it more difficultPete McCleave first heard about stem cells during his sciences degree in the 1990s. “I knew about them, I just didn’t know what they could be used for,” he says. “It all sounded very pie in the sky.” It wasn’t until two decades later when McCleave was diagnosed with myeloma blood cancer that he came across stem cells again. This time, he needed them to save his life.“I was told that really the only chance I have, the best chance I have in seeing beyond the seven years I was given [to live] was finding a stem ...
Source: Guardian Unlimited Science - March 22, 2024 Category: Science Authors: Mabel Banfield-Nwachi Tags: Cancer Health Stem cells Biology Science Society UK news Source Type: news

Petri Dish: Pi announces fundraise on Pi Day; Gamida exec ’s new job
In today ’s Petri Dish we look at the latest fundraises, a potential drug label expansion for myeloma patients and GRObio’s new chief development officer. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - March 21, 2024 Category: Biotechnology Authors: Hannah Green Source Type: news

Myeloma: FDA Advisers Greenlight Early CAR-T Myeloma: FDA Advisers Greenlight Early CAR-T
An FDA advisory panel endorsed earlier use of CAR-T therapies to treat multiple myeloma but emphasized the importance of informing patients about potential risks associated with these treatments.MDedge News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - March 21, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology Source Type: news

FDA Panel Gives Thumbs Up to Earlier Use of CAR T-Cell Therapy in Multiple Myeloma
(MedPage Today) -- Two CAR T-cell therapies for multiple myeloma won favorable recommendations for earlier use in the disease during a day-long meeting of the FDA Oncologic Drugs Advisory Committee (ODAC). By an 11-0 vote, ODAC recommended that... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 17, 2024 Category: American Health Source Type: news

Early Death Risk Muddies Risk-Benefit Assessment of CAR-T Therapies for Myeloma
(MedPage Today) -- An increased risk of early death has created uncertainty about the risk-benefit ratio of two CAR T-cell therapies for relapsed/refractory multiple myeloma, which an FDA advisory committee will consider on Friday. Both ciltacabtagene... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 14, 2024 Category: American Health Source Type: news

Using Patient-Reported Outcomes to Measure Frailty in Patients with Multiple Myeloma
Frailty measures that use patient self-reports called “patient-reported outcomes” (PROs) can provide scientific information on a patient’s experience coming directly from patients. PROs can offer valuable information about a patient’s own health, quality of life, and functional capabilities, (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news