Source: Pharmacy Times articles

Venetoclax, which is approved for leukemia, blocks a function of the BCL-2 protein and has previously shown efficacy in a small proportion of patients with multiple myeloma.
Read More

Source: Pharmacy Times articles

The indication is for adult patients with multiple myeloma who are refractory to lenalidomide and have previously received at least 1 line of therapy.
Read More

Source: Pharmacy Times articles

Kirollos Hanna, PharmD, BCPS, BCOP, FACCC, addresses some of the considerations for bispecifics in relation to facility readiness at different sites and among different stakeholders.
Read More

Source: Myeloma : nature.com subject feeds

Post Content

Read More

Source: Myeloma : nature.com subject feeds

Post Content

Read More

Source: Myeloma : nature.com subject feeds

Post Content

Read More

Source: Myeloma – Hematology Advisor

The Food and Drug Administration (FDA) has approved Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after 2 or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (triple-class-refractory). This approval allows patients with relapsed/refractory multiple myeloma to receive the T-cell therapy earlier than previously indicated.

Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. It is a customized treatment using the patient’s own T cells that have been genetically modified to include a new gene to target and destroy myeloma cells. Antigen-specific activation of Abecma results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

The expanded approval was based on data from the KarMMa-3 study (ClinicalTrials.gov Identifier: NCT03651128), which evaluated Abecma in patients with relapsed or refractory multiple myeloma who had received 2 to 4 lines of prior therapy. Study participants were randomly assigned to receive Abecma (n=254) or standard regimens (n=132). The primary endpoint was progression free survival (PFS); other measures included overall response rate and overall survival.

Results showed treatment with Abecma led to statistically significant improvement in PFS compared with standard regimens (hazard ratio, 0.49 [95% CI, 0.38-0.64]; P <.0001). Median PFS was 13.3 months (95% CI, 11.8-16.1) in the Abecma arm and 4.4 months (95% CI, 3.4-5.9) in the standard regimens arm. 

Overall response rate was 71% (95% CI, 66-77) with Abecma and 42% (95% CI, 33-50) with standard regimens (P <.0001). Median duration of response (DOR) was 14.8 months (95% CI, 12.0-18.6) in the Abecma group and 9.7 months (95% CI, 5.4-16.3) in the standard regimens group. In those patients with complete response or better, the median DOR was 20 months (95% CI, 15.8-24.3). At the time of data cutoff, overall survival data were immature.

“Abecma has demonstrated a progression free survival benefit 3 times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the promise of cell therapy to patients earlier in their treatment journey,” said Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb.

As for safety, cytokine release syndrome occurred in 88% of patients who received Abecma; 5% of events were grade 3 or higher. Neurotoxic effects occurred in 15% of the Abecma-treated patients; 3% were grade 3 or higher.

The prescribing information for Abecma includes a Boxed Warning regarding the risk of cytokine release syndrome, neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged cytopenia, all of which can be fatal or life-threatening. It is available only through a restricted program called the Abecma REMS.

Abecma is administered as a single dose for infusion containing a suspension of CAR- positive T cells in 1 or more infusion bags. The new recommended dose range is 300 to 510 x 106 CAR-positive T cells.

Read More

Source: Pharmacy Times articles

The approval expands the prior indication of idecabtagene vicleucel (Abecma; Bristol Myers Squibb), which will make the drug available to patients in earlier lines.
Read More

Source: Pharmacy Times articles

FDA-approved BiTE therapies for relapsed/refractory multiple myeloma show promising response rates, offering off-the-shelf alternatives to CAR T therapy.
Read More

Source: Myeloma – Hematology Advisor

Preventive photobiomodulation (PBM) appears to be more effective than a curative approach for mitigating the effects of oral mucositis (OM) among patients undergoing hematopoietic stem cell transplantation (HSCT) for multiple myeloma (MM), according to research published in Supportive Care in Cancer.

OM is associated with significant issues in this patient population, including systemic infection and consequent hospitalization. Moreover, this adverse event is associated with a significant amount of pain, and reduces patient quality of life.

PBM is increasingly becoming recognized as an effective strategy against OM, though protocols around PBM are not well established. For this retrospective study, researchers compared the safety and efficacy of curative vs preventive PBM against OM among patients with MM undergoing HSCT.

Overall, data from 24 patients were included, of whom 12 each received curative or preventive PBM. In the preventive and curative PBM groups, the mean ages were 59.3 and 55.9 years, respectively, 66.7% and 41.7% of patients were male gender, and transplantation engraftment rates were 100% and 100%. All patients developed OM.

Analysis showed that, after HSCT, preventive PBM was superior to curative PBM for reducing both OM severity and pain (both P <.0001). Patients in the preventive PBM group also reported lower rates of discomfort when swallowing, chewing, or speaking than did those in the curative PBM group. No adverse events deemed related to therapy were noted.

“With the limitation of the sample size, our results show how the timing for the beginning of PBM therapy in patients undergoing HSCT is crucial: when started on the first day of conditioning, it significantly reduces both pain and OM severity, providing an important benefit also in subjective oral functions such as speaking, swallowing, and chewing and increasing overall tolerance of the procedure,” the authors wrote in their report.

Read More