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Multiple Myeloma

All articles tagged with #multiple myeloma

60-year-old dad plans his funeral after acid reflux misdiagnosis uncovers cancer
health17 days ago

60-year-old dad plans his funeral after acid reflux misdiagnosis uncovers cancer

A 60-year-old man from Newcastle, Ian Swindell, was repeatedly diagnosed with acid reflux for months before a bone marrow biopsy revealed incurable multiple myeloma. He underwent emergency radiotherapy and chemotherapy, now relies on a walking stick and wheelchair, and is planning his own funeral to ease the burden on his kids, while urging others to seek second opinions when something feels wrong and to listen to their bodies.

via Yahoo|
#acid-reflux#cancer#health
FDA grants third CNPV-backed approval for Tec-Dara myeloma therapy
health1 month ago

FDA grants third CNPV-backed approval for Tec-Dara myeloma therapy

The FDA approved teclistamab with daratumumab hyaluronidase-fihj (Tec-Dara) for adults with relapsed/refractory multiple myeloma after at least one prior therapy, marking the third approval under the Commissioner's National Priority Voucher (CNPV) program; the Phase 3 trial showed an 83% reduction in the risk of disease progression or death and improvements in progression-free and overall survival versus standard of care, with Tec-Dara subject to a REMS due to risks such as cytokine release syndrome and immune effector cell–associated neurotoxicity (ICANS); the Tecvayli (teclistamab-cqyv) monotherapy indication will be converted from accelerated to traditional approval based on the same study.

via fda.gov|
#fda#health#multiple-myeloma
business1 month ago

Gilead to Acquire Arcellx for $7.8B to Accelerate Anito-cel and CAR-T Platform

Gilead will acquire Arcellx for $115 per share in cash plus a $5-per-share contingent value right (CVR), valuing the deal at about $7.8 billion and giving Gilead full control of Anito-cel, its BCMA-directed CAR-T therapy for multiple myeloma. The transaction aims to accelerate development and commercialization, with Anito-cel’s BLA accepted by the FDA and a PDUFA date of December 23, 2026; the deal is expected to close in Q2 2026 and to be accretive to EPS after FDA approval, with the CVR tied to cumulative global net sales milestones through 2029.

via Gilead Sciences|
#anito-cel#arcellx#business
FDA Drafts MRD-Based Path to Speed Myeloma Drug Approvals
health-policy2 months ago

FDA Drafts MRD-Based Path to Speed Myeloma Drug Approvals

The FDA released a draft guidance proposing minimal residual disease (MRD) and complete response (CR) as endpoints to support accelerated approvals for multiple myeloma. The document outlines trial design, timing, and MRD thresholds (MRD negativity at 10^-5, assessed around CR), with MRD potentially serving as an independent endpoint alongside CR, while noting MRD’s limitations—no use in maintenance or smoldering myeloma—and that the guidance is nonbinding. Issued after ODAC support but amid leadership changes, the guidance aims to speed access to new therapies (notably for CAR‑T and T‑cell engagers), though final approvals remain at the FDA’s discretion and unproven to guarantee OS benefits.

via Fierce Biotech|
#accelerated-approval#clinical-trials#fda
GSK’s Blenrep Gains US FDA Approval for Blood Cancer Treatment
healthcare5 months ago

GSK’s Blenrep Gains US FDA Approval for Blood Cancer Treatment

The US FDA has approved GSK's Blenrep in combination with bortezomib and dexamethasone for treating relapsed/refractory multiple myeloma in patients who have received at least two prior therapies, based on positive results from the DREAMM-7 trial showing significant survival benefits. Blenrep is notable for its community accessibility and ongoing development in earlier treatment lines.

via GSK|
#blenrep#cancer-treatment#fda-approval
Bristol Myers Squibb's Iberdomide Shows Promise in Improving MRD Negativity in Multiple Myeloma
healthcare6 months ago

Bristol Myers Squibb's Iberdomide Shows Promise in Improving MRD Negativity in Multiple Myeloma

Bristol Myers Squibb announced that their Phase 3 EXCALIBER-RRMM study showed that combining iberdomide with standard therapies significantly improved minimal residual disease negativity rates in relapsed or refractory multiple myeloma patients, with the trial continuing to evaluate other endpoints.

via Bristol Myers Squibb|
#bristol-myers-squibb#clinical-trial#healthcare
High-Fiber Diets Linked to Reduced Blood Cancer Risk and Progression
health1 year ago

High-Fiber Diets Linked to Reduced Blood Cancer Risk and Progression

A new study suggests that a high-fiber, plant-based diet may help prevent the progression of monoclonal gammopathy of undetermined significance (MGUS) to multiple myeloma, a common form of blood cancer. Conducted on 20 MGUS patients, the research found that dietary changes led to weight loss, improved insulin resistance, and a healthier gut microbiome, all contributing to a slowdown in disease progression. The findings, presented at the American Society of Hematology meeting, highlight the potential of nutrition in cancer prevention, with a larger study planned to further explore these results.

via Newsmax|
#blood-cancer#health#high-fiber-diet
FDA Advisory Committee Unanimously Approves MRD as Endpoint for Myeloma Trials
healthcare2 years ago

FDA Advisory Committee Unanimously Approves MRD as Endpoint for Myeloma Trials

The FDA's Oncologic Drugs Advisory Committee voted 12 to 0 in favor of using minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma clinical trials. This decision could potentially lead to earlier access to effective treatments for patients and the possibility of stopping therapy based on MRD. The use of MRD as an endpoint in different myeloma disease settings and the acceptability of time points for MRD assessment were also discussed during the meeting.

via Targeted Oncology|
#clinical-trials#fda#healthcare
"House Majority Leader Steve Scalise to Receive Stem Cell Transplant, Temporarily Steps Down"
politics2 years ago

"House Majority Leader Steve Scalise to Receive Stem Cell Transplant, Temporarily Steps Down"

House Majority Leader Steve Scalise will be absent from Washington until February to undergo a stem cell transplant for his multiple myeloma treatment, impacting the already narrow Republican majority in the House. This comes at a critical time with looming government shutdown deadlines and the need for bipartisan support to pass legislation. Scalise, who has served as a leadership mentor to Speaker Mike Johnson after being unable to secure the speakership himself, will work remotely during his recovery. His medical challenges, including a previous critical injury from a shooting, highlight his resilience in the face of health issues.

via The Washington Post|
#government-shutdown#house-republicans#multiple-myeloma
"Poseida Therapeutics' Allogeneic CAR-T Shows Promising Results in Multiple Myeloma Trial"
healthcare2 years ago

"Poseida Therapeutics' Allogeneic CAR-T Shows Promising Results in Multiple Myeloma Trial"

Poseida Therapeutics presented positive early results from its Phase 1 trial of P-BCMA-ALLO1, an allogeneic CAR-T therapy, in relapsed/refractory multiple myeloma (RRMM) at the 65th American Society of Hematology (ASH) Annual Meeting. The therapy demonstrated an 82% overall response rate (ORR) and deep clinical responses in heavily pretreated patients, with no graft-vs-host disease (GvHD) or dose-limiting toxicities observed. The therapy also showed promising persistence and differentiation of CAR-T cells, supporting the potential of allogeneic T stem cell memory (TSCM)-rich CAR-T therapies. Poseida Therapeutics plans to continue developing P-BCMA-ALLO1 in partnership with Roche.

via PR Newswire|
#allogeneic-therapy#car-t-therapy#clinical-trial