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Multiple Myeloma

All articles tagged with #multiple myeloma

Sanofi wins FDA nod for subcutaneous Sarclisa with on-body injector
health4 days ago

Sanofi wins FDA nod for subcutaneous Sarclisa with on-body injector

The FDA approved Sanofi’s Sarclisa Escena, a subcutaneous version of Sarclisa that can be delivered by hand or Enable Injections’ CirCLIQ on-body injector, marking the first subcutaneous anticancer therapy usable with an OBI. In a phase 3 trial in relapsed/refractory multiple myeloma after at least one prior line, Sarclisa Escena plus pomalidomide and dexamethasone achieved an objective response rate of 71.1%—non-inferior to 70.5% with the IV Sarclisa–pomalidomide–dexamethasone regimen—while reducing administration time. The device’s rollout positions Sanofi to better compete with Johnson & Johnson’s Darzalex Faspro. Europe had already cleared OBIs for Sarclisa, and J&J highlighted Darzalex’ broader indications and established, monthly dosing in its own subcutaneous form.

via Fierce Pharma|
#darzalex-competition#fda-approval#health
J&J CEO projects cancer elimination within a decade through immunotherapy breakthroughs
health26 days ago

J&J CEO projects cancer elimination within a decade through immunotherapy breakthroughs

At the WSJ Leadership Institute summit, Johnson & Johnson CEO Joaquin Duato said the company aims to eliminate cancer within 10 years, citing breakthroughs in immunotherapy that have extended remission in multiple myeloma and improved longevity, with AI and biomarkers enabling earlier diagnosis and more personalized treatments. He suggested some cancers could be cured while others become chronic, and noted J&J's acquisitions like Firefly Bio to target difficult mutations, alongside advances such as a melanoma vaccine study by Merck and Moderna that underscores rapid progress in oncology.

via Fox News|
#cancer-cure-timeline#cancer-research#health
One-time CAR-T therapy Carvykti reshapes myeloma care and biotech leadership
health1 month ago

One-time CAR-T therapy Carvykti reshapes myeloma care and biotech leadership

Multiple myeloma, a brutal blood cancer, is increasingly treatable thanks to CAR-T immunotherapy, especially Carvykti, a BCMA-targeting one-time infusion that has produced durable remissions and in some cases cures. Developed in China and licensed to a Western company, Carvykti’s success—with CARTITUDE-1 showing a 76% response rate and five-year data indicating about 33% disease-free—highlights a shift in biotech leadership from the US to China, driven by faster early-stage trials and regulatory reforms. The US still dominates late-stage development, but China’s rapid trial ecosystem is accelerating the global pipeline, potentially enabling earlier, even first-line, use of such therapies and signaling a broad realignment in drug discovery and approval.

via Works in Progress Magazine|
#bcma#biotech-regulatory-reform#car-t-therapy
Lilly-backed in vivo CAR-T delivers durable MRD-negativity in multiple myeloma
healthcare1 month ago

Lilly-backed in vivo CAR-T delivers durable MRD-negativity in multiple myeloma

Kelonia Therapeutics’ KLN-1010, an off-the-shelf in vivo CAR-T for BCMA in relapsed/refractory multiple myeloma, produced MRD-negativity in all 18 treated patients at one month, with all assessable patients remaining MRD-negative at six months and the longest follow-up over 10 months. The safety profile is favorable (mostly grade 1–2 CRS and two ICANS cases). Lilly’s $3.2 billion deal for Kelonia could accelerate moving KLN-1010 into earlier lines and set the stage for phase 3 trials and broader in vivo CAR-T applications across cancer types.

via Fierce Biotech|
#healthcare#in-vivo-car-t#kelonia
60-year-old dad plans his funeral after acid reflux misdiagnosis uncovers cancer
health3 months 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
health4 months 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
business4 months 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-policy5 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
healthcare8 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
healthcare9 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