Abecma OK’d in US to take earlier in treatments for multiple myeloma
Myeloma Research News
by Andrea Lobo
2w ago
The U.S. Food and Drug Administration (FDA) has expanded the indication of Abecma (idecabtagene vicleucel) to allow its use earlier in the therapy regimen for adults with difficult-to-treat multiple myeloma. The CAR T-cell therapy, developed by Bristol Myers Squibb (BMS) and 2seventy bio, was already approved in the U.S. for people with relapsed or refractory myeloma (RRMM) who received at least four previous lines of therapy. Eligible patients had to be triple-class exposed, meaning they received at least one immunomodulatory drug, one proteasome inhibitor, and one CD38 inhibitor. The increa ..read more
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Steroid-free Venclexta combo shows promise in myeloma cells
Myeloma Research News
by Lindsey Shapiro, PhD
3w ago
Combining the cancer therapy Venclexta (venetoclax) with a molecule called 5-azacytidine (5-aza) increased the former’s ability to kill lab-grown cancer cells derived from a range of different multiple myeloma patients regardless of their disease stage, a study showed. While Venclexta is known to benefit only myeloma patients with a specific genetic variant or with high levels of the cell survival protein BCL2, the addition of 5-aza made cells from patients with other genetic backgrounds more sensitive to the treatment. Researchers believe the addition of 5-aza to Venclexta — a combination al ..read more
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Abecma cleared in EU as earlier therapy for hard-to-treat myeloma
Myeloma Research News
by Lindsey Shapiro, PhD
1M ago
The European Commission has approved Bristol Myers Squibb (BMS)’s request to expand the use of the CAR T-cell therapy Abecma (idecabtagene vicleucel) as an earlier line of therapy for adults with multiple myeloma that’s difficult to treat. The therapy was already approved in the European Union (EU) for people with relapsed or refractory myeloma (RRMM) who’d received three prior lines of therapy. All patients would have been triple-class exposed, meaning they’d have received the most common standard treatment classes: immunomodulators, proteasome inhibitors, and CD38 inhibitors. With the ..read more
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CAR T-cell therapy recommended as earlier treatment line for RRMM
Myeloma Research News
by Andrea Lobo
1M ago
An advisory committee of the U.S. Food and Drug Administration (FDA) has unanimously recommended extending the approval of Janssen’s Carvykti (ciltacabtagene autoleucel) as an earlier line of treatment for adults with relapsed or refractory multiple myeloma (RRMM). The 11 -0 vote by the Oncologic Drugs Advisory Committee was based on safety and survival data from the Phase 3 CARTITUDE-4 clinical trial (NCT04181827) that showed a favorable risk-benefit assessment for the therapy, which is available in the U.S. for adults who’ve received at least four prior lines of therapy, including a proteas ..read more
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Approval of a Darzalex Faspro therapy combo is sought in Europe
Myeloma Research News
by Patricia Inácio, PhD
1M ago
Johnson & Johnson has applied to the European Medicines Agency (EMA) for approval of its under-the-skin formulation of Darzalex (daratumumab), called Darzalex Faspro (daratumumab and hyaluronidase-fihj), in combination with a standard triple-therapy regimen for treating adults with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. The application is supported by four-year data from the Phase 3 PERSEUS trial (NCT03710603), which enrolled 709 adults with newly diagnosed multiple myeloma who were eligible for a standard autologous stem cell transplant, accord ..read more
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FDA OKs less frequent Tecvayli dosing for treatment responders
Myeloma Research News
by Lindsey Shapiro, PhD
1M ago
The U.S. Food and Drug Administration (FDA) has cleared an every-other-week dosing regimen of Tecvayli (teclistamab) for relapsed or refractory (hard-to-treat) multiple myeloma (RRMM) patients who have responded well to the therapy’s standard weekly dosing. Tecvayli was initially approved in 2022 for adults with RRMM who had received at least four prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and a CD38 inhibitor. The medication from Janssen, now known as Johnson & Johnson Innovative Medicine, was indicated for use at a weight-based dose of 1.5 mg/kg, d ..read more
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Myeloma Action Month to focus on bringing hope through action
Myeloma Research News
by Mary Chapman
2M ago
Myeloma Action Month (MAM) is observed each March to call attention to multiple myeloma and the people affected by it, and this year’s event will focus on bringing hope to patients and caregivers through action. The international campaign is designed to improve awareness of myeloma among policymakers, researchers, public authorities, health professionals, and industry representatives, along with the general public. Myeloma accounts for 10% of all blood cancers and is the second most common blood malignancy in the world, but many people have never heard of it, The disorder is often confused wi ..read more
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Elrexfio now approved in Canada as recurring myeloma treatment
Myeloma Research News
by Margarida Maia, PhD
2M ago
Health Canada has granted conditional approval to Pfizer’s Elrexfio (elranatamab-bcmm), expanding the list of countries where the medication can be used for adults with multiple myeloma whose cancer has returned and who have not responded to previous treatment. The conditional approval, officially a Notice of Compliance, will require Pfizer to undertake additional studies to verify the clinical benefit of Elrexfio in patients. Those studies must involve people with myeloma who have received at least three prior lines of therapy — a proteasome inhibitor, an immunomodulatory agent, and a&n ..read more
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Blenrep delays disease progression by nearly 3X versus Darzalex
Myeloma Research News
by Patricia Inácio, PhD
2M ago
GlaxoSmithKline (GSK)’s Blenrep (belantamab mafodotin) significantly reduced by more than half the risk of disease progression or death in people with relapsed or refractory multiple myeloma (RRMM) relative to Darzalex (daratumumab). A nearly three times greater delay in disease progression and a 43% lower risk of death was associated with Blenrep-treated patients over those on Darzalex, according to a two-year interim analysis of the global Phase 3 DREAMM-7 clinical trial (NCT04246047) that’s testing Blenrep versus Darzalex when added to a standard combination of Velcade (bort ..read more
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Regeneron seeking approval of linvoseltamab for RRMM in US, EU
Myeloma Research News
by Lindsey Shapiro, PhD
2M ago
The European Medicines Agency has agreed to review Regeneron Pharmaceuticals’ application seeking approval of its investigational therapy linvoseltamab for adults in Europe with relapsed or refractory multiple myeloma (RRMM), according to a company press release. A similar application was submitted to the U.S. Food and Drug Administration in December. Both submissions seek clearance of the antibody-based therapy for RRMM patients whose disease progressed despite at least three prior lines of therapy — specifically, a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antib ..read more
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