multiple myeloma

Janssen have submitted a Marketing Authorisation Application (MAA) to the EMA seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma.

The submission of the application follows the positive results from the ongoing Phase 1b/2 CARTITUDE-1 study, investigating the safety and efficacy of cilta-cel.

Sanofi’s Sarclisa drug has been approved by the FDA in combination with carfilzomib and dexamethasone (Kd) for the treatment of relapsed or refractory multiple myeloma (rrMM) for adult patients who have already received at least one prior line of therapy.

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.

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.

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 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’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”.

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.

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 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.