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multiple myeloma

NICE approves Sanofi's Sarclisa combo for relapsed/refractory multiple myeloma

Sanofi’s Sarclisa (isatuximab) has secured a recommendation from NICE for routine use on the NHS in England and Wales as a treatment for relapsed/refractory multiple myeloma (RRMM) when combined with standard care pomalidomide and dexamethasone.

The therapy is specifically approved for use in adults who have received three lines of therapy and previously been treated with at least two treatments including lenalidomide and a proteasome inhibitor, with their disease progressing since their most recent treatment.

FDA committee backs GSK's belantamab mafodotin in relapsed or refractory multiple myeloma

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has moved to recommend the use of GlaxoSmithKline’s belantamab mafodotin, or GSK2857916 as it is also known, as a monotherapy in the treatment of relapsed or refractory multiple myeloma, the pharma company reported.

The committee voted 12-0 in favour of recommending the therapy due to its positive benefit/risk profile based on supplied six-month efficacy data, though it was noted that two committee members were unable to take part in the final vote.

100% of multiple myeloma patients respond to Janssen's investigational CAR T therapy, data shows

Janssen has revealed new Phase1b/2 findings of the efficacy of its investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, known as JNJ-4528, in the treatment of relapsed or refractory multiple myeloma

The company reported that the findings revealed a 100% response rate among participants to the therapy, and this breaks down into 97% achieving a “very good partial response or better” and 3% achieving a partial response.

Takeda's Ninlaro combo fails to hit main goal in newly diagnosed, transplant ineligible multiple myeloma

Takeda has unveiled new Phase 3 data for its oral proteasome inhibitor Ninlaro (ixazomib) in the treatment of newly diagnosed transplant ineligible multiple myeloma, revealing that the therapy, when combined with lenalidomide and dexamethasone, unfortunately did not meet its primary endpoint.

The combo was shown to improve median progression-free survival by 35.3 months compared to 21.8 months with lenalidomide and dexamethasone alone – an overall improvement of 13.5 months, but this was not to a degree that was considered statistically significant.

Sanofi scores FDA approval for Sarclisa combo in relapsed, refractory multiple myeloma

Sanofi’s monoclonal antibody and CD-38 inhibitor Sarclisa (isatuximab-irfc) has been awarded marketing authorisation from the FDA in the treatment of relapsed, refractory multiple myeloma (RRMM)

The therapy is approved in combination with pomalidomide and dexamethasone (pom-dex) in adult patients who have previously received two prior therapies including lenalidomide and a proteasome inhibitor. According to Sanofi, the therapy will be available “shortly”.

FDA fast-tracks GSK's multiple myeloma drug after priority review

The FDA has fast tracked GlaxoSmithKline (GSK) antibody drug conjugate (ADC) belantamab mafodotin, for the treatment of patients with refractory or relapsed multiple myeloma.

The drug delivers a cytotoxic pharmaceutical agent to myeloma cells expressing the antigen BCMA.

Myeloma UK reveals new Director of Research appointment

UK non-profit organisation Myeloma UK has selected Sarah McDonald as its new Director of Research, who in her new role will galvanise research and patient advocacy efforts within the company in the spirit of “advancing the organisation’s impact within the blood cancer research community”.

McDonald joins the organisation from fellow non-profit Sarcoma UK where she served as Director of Research and Policy. In the role, she led the organisation’s research programme and was a key player in securing £870,000 worth of funding for its clinical, lab-based and genomic research projects.

Takeda's Ninlaro shows progression-free survival benefit in multiple myeloma

Takeda has revealed strong new findings for Ninlaro (ixazomib), confirming that the therapy met its primary endpoint as a first-line maintenance treatment of multiple myeloma in adult patients not treated with stem cell transplantation.

In a Phase 3 study incorporating 706 multiple myeloma patients who had completed 6-12 months of initial therapy and achieved a partial response or better, Ninlaro demonstrated a “statistically significant” improvement in progression free survival compared to placebo, meeting its primary endpoint.

Amgen's Kyprolis + Darzalex combo shows progression-free survival benefit in multiple myeloma

Amgen has revealed new Phase 3 data for the combination of Kyprolis (carfilzomib) and Darzalex (daratumumab) in addition to the steroid dexamethasone, showing that the combo met its primary endpoint of progression-free survival (PFS) in the treatment of multiple myeloma (MM) compared to Kyprolis and dexamethasone alone.

The findings showed that the three-drug regimen reduced the risk of progression or death in patients with relapsed or refractory MM by 37% compared to the two-drug combination.

FDA approves multiple myeloma therapy Xpovio despite safety concerns

The FDA has made the controversial decision to approve the nuclear export inhibitor Xpovio (selinexor) from Karyopharm Therapeutics, in combination with dexamethasone, in the treatment of a sub-population of relapsed or refractory multiple myeloma (RRMM) patients, despite an advisory panel recommending against approval earlier this year.

 The US agency chose to approve the drug under its accelerated pathway for adult RRMM patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory

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