Approved Myeloma Drug in Limbo After Negative ODAC Review
(MedPage Today) -- The FDA's Oncologic Drugs Advisory Committee (ODAC) may have dealt a decisive blow to the dangling accelerated approval of melphalan flufenamide (Pepaxto) for multiple myeloma.
By a decisive 14-2 margin, ODAC voted on Thursday... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - September 23, 2022 Category: Hematology Source Type: news
FDA/IMS Joint Workshop: Future of Drug Development in Multiple Myeloma - 11/08/2022
On November 8-9, 2022, the U.S. Food and Drug Administration (FDA) and the International Myeloma Society (IMS) will host a joint symposium, to provide a forum for open discussion among academia, industry, and regulatory agencies about clinical drug development in multiple myeloma. The event will be held in person and online. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Photon - Counting Detector CT Helps ID Multiple Myeloma Lesions
Use of PCD CT images with convolutional neural network denoising improves viewing of pathologic abnormalities, detects lytic lesions (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - September 19, 2022 Category: Cancer & Oncology Tags: Oncology, Radiology, Journal, Source Type: news
FDA/IMS Joint Workshop: Future of Drug Development Clinical Drug Development in Multiple Myeloma - 11/08/2022
On November 8-9, 2022, the U.S. Food and Drug Administration (FDA) and the International Myeloma Society (IMS) will host a joint symposium, to provide a forum for open discussion among academia, industry, and regulatory agencies about clinical drug development in multiple myeloma. The event will be held in person and online. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 19, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Photon-Counting Detector CT Helps ID Multiple Myeloma Lesions
MONDAY, Sept. 19, 2022 -- Photon-counting detector (PCD) computed tomography (CT) with deep learning noise reduction may improve spatial resolution for viewing findings in multiple myeloma compared with energy-integrating detector (EID) CT,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 19, 2022 Category: Pharmaceuticals Source Type: news
T - Cell Redirection Therapy Studied for Relapsed Multiple Myeloma
Sequential use of different T - cell therapies may lead to durable responses following relapse after bispecific antibody therapy (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - September 15, 2022 Category: Cancer & Oncology Tags: Oncology, Pathology, Journal, Source Type: news
T-Cell Redirection Therapy Studied for Relapsed Multiple Myeloma
THURSDAY, Sept. 15, 2022 -- In patients with heavily pretreated relapsed/refractory multiple myeloma with relapse after bispecific antibody (BiAb) T-cell redirection therapy, subsequent T-cell redirection therapy is feasible as salvage therapy,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 15, 2022 Category: Pharmaceuticals Source Type: news
Risk for MGUS Up in WTC - Exposed Rescue/Recovery Workers
Risk for myeloma precursor disease, monoclonal gammopathy of undetermined significance, increased among WTC - exposed workers (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - September 8, 2022 Category: Cancer & Oncology Tags: Internal Medicine, Oncology, Pathology, Journal, Source Type: news
Risk for MGUS Up in WTC-Exposed Rescue/Recovery Workers
THURSDAY, Sept. 8, 2022 -- World Trade Center (WTC)-exposed rescue/recovery workers have an increased risk for the myeloma precursor disease monoclonal gammopathy of undetermined significance (MGUS), according to a study published online Aug. 22 in... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 8, 2022 Category: Pharmaceuticals Source Type: news
Episode 6: Racial and Ethnic Disparities in Multiple Myeloma Episode 6: Racial and Ethnic Disparities in Multiple Myeloma
Drs Joseph Mikhael and Brandon Blue reveal the impact of disparities in multiple myeloma and pave a path forward to culturally competent care.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 6, 2022 Category: Consumer Health News Tags: Hematology-Oncology InDiscussion Source Type: news
At-Risk Groups Underrepresented in Cancer Trials Leading to Approvals
(MedPage Today) -- At-risk populations -- particularly Black and Hispanic patients -- are significantly underrepresented in pivotal clinical trials for leukemias and multiple myeloma, a recent analysis showed.
Among 41 trials that led to FDA... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - August 31, 2022 Category: Hematology Source Type: news
Bispecific Antibody Active in Heavily Treated Multiple Myeloma
(MedPage Today) -- Almost 60% of patients with heavily pretreated multiple myeloma responded to an investigational bispecific antibody, results from an ongoing phase I trial showed.
Overall, 57% of 124 patients had at least partial response to... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - August 30, 2022 Category: Hematology Source Type: news
Final Analysis of Phase 2 GRIFFIN Study Presented for DARZALEX ® (daratumumab)-based Investigational Quadruplet Regimen in Patients with Newly Diagnosed, Transplant-Eligible Multiple Myeloma
LOS ANGELES, August 27, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the final results from the randomized Phase 2 GRIFFIN study evaluating the investigational use of DARZALEX® (daratumumab) in combination with lenalidomide (Revlimid®), bortezomib (VELCADE®) and dexamethasone (DARZALEX®-RVd), followed by maintenance therapy with DARZALEX®-lenalidomide (R), compared to RVd followed by maintenance therapy with R alone, in patients with newly diagnosed, transplant-eligible multiple myeloma. Data were presented in the plenary session at the 19th International Myeloma Society (IMS)...
Source: Johnson and Johnson - August 28, 2022 Category: Pharmaceuticals Source Type: news
Myeloma Risk in 9/11 Workers; New Ibrutinib Indication; Help for Chemo Brain?
(MedPage Today) -- More evidence that first responders and clean-up crews at the site of the World Trade Center continue to have a heightened risk for multiple myeloma and the precursor condition monoclonal gammopathy of uncertain significance... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - August 26, 2022 Category: Hematology Source Type: news
Janssen Marks First Approval Worldwide for TECVAYLI ® (teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma
BEERSE, BELGIUM, August 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted conditional marketing authorisation (CMA) of TECVAYLI® (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.[1] Today’s milestone marks the first approval worldwide for teclistamab, a first-i...
Source: Johnson and Johnson - August 24, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
