Multiple Myeloma

Isatuximab-irfc (Sarclisa; sanofi-aventis) provides patients with another option for treatment and significantly reduces the risk of disease progression or death.

In an interview with Pharmacy Times®, Maria Whitman, Global Head of the Pharmaceutical and Biotech Practice at ZS, discusses the FDA’s Project Optimus, the FDA’s new guidance addressing dose optimization issues in oncology clinical trials, and how it has impacted drug manufacturers.

Robert Z. Orlowski, MD, PhD, director of the Myeloma Section at the University of Texas MD Anderson Cancer Center, reviewed novel agents in the treatment of triple-class refractory myeloma during a session at the 2021 annual meeting of the Society of Hematologic Oncology (SOHO).

A presentation at the Society of Hematologic Oncology 2021 Annual Meeting reviewed the treatment of amyloidosis in multiple myeloma.

Presenter Maria-Victoria Mateos, MD, PhD, University Hospital of Salamanca-IBSAL, Salamanca, Spain, discussed how optimal sequencing in MM has changed from those outlined in the older EU guidelines.

Nearly 20% of patients with multiple myeloma have a form of the disease in which they make high quantities of a component of monoclonal proteins, which damages the kidneys.

The FDA has granted orphan drug designation to CFT7455 for the treatment of multiple myeloma, according to a press release from manufacturer C4 Therapeutics.

Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) was approved in July in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma following their first or subsequent relapse.

According to the investigators, treatment with ruxolitinib resulted in a significant improvement in ORR after 24 weeks, with an ORR of 49.7% in the ruxolitinib arm compared to 25.6% in the best available therapy arm.

Despite the encouraging progression-free survival findings, data on overall survival resulted in a partial clinical hold instituted by the FDA.

Results from the APOLLO trial showed a significant 37% reduction in the risk of progression or death, compared to pomalidomide and dexamethasone alone in patients with multiple myeloma.

The drug is approved for patients after 4 or more failed lines of therapy, although many patients in clinical trials had received 7 or more prior lines of therapy.

Coordinating complex care plans can involve many care team members and even different pharmacists in both health system and retail environments.

Pharmacists can educate patients about a pair of new treatment options for multiple myeloma approved by the FDA in March 2021.

Teclistamab is an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors.

Selinexor in combination with bortezomib and dexamethasone is used for adult patients with multiple myeloma who have received at least 1 prior therapy.

Ssatuximab (Sarclisa, Sanofi) is used in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma.

Melphalan flufenamide (Pepaxto; melflufen) is approved for use in combination with dexamethasone to treat adult patients with relapsed or refractory multiple myeloma.

Isatuximab in combination with carfilzomib and dexamethasone reduced the risk of disease progression or death by 45% versus standard of care alone.

In a clinical trial of idecabtagene vicleucel in multiple myeloma, the overall response rate for the efficacy evaluable population was 72%, and 28% of participants achieved a stringent complete response.

Bristol Myers Squibb and bluebird bio are seeking FDA approval for ide-cel as a standard therapy for relapsed myeloma, with a decision expected by the end of March.

Teclistamab showed promising clinical activity and a tolerable safety profile in patients with relapsed/refractory multiple myeloma.

The FDA has approved melphalan flufenamide (Pepaxto; melflufen) for use in combination with dexamethasone to treat adult patients with relapsed or refractory multiple myeloma.

The FDA has granted an orphan drug designation to the BCMA-targeted trispecific T-cell activating recombinant protein construct as treatment for patients with multiple myeloma.

Three monoclonal antibodies, 1 antibody-drug conjugate, and 1 nuclear export inhibitor have been approved by the FDA for relapsed/refractory (R/R) multiple myeloma in the past 4 years.

Selinexor (Xpovio; Karyopharm Therapeutics Inc.) in combination with bortezomib (Velcade; Takeda) and dexamethasone was approved for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy.

CAR T-cell therapy associated with greater anti-cancer activity in treating multiple myeloma.

For patients with relapsed/refractory multiple myeloma (RRMM), teclistamab was found to have a manageable safety profile, according to data presented at the virtual American Society of Hematology conference.

Data from a preliminary phase 1b/2 study demonstrated a single low-dose infusion of ciltacabtagene autoleucel resulted in early, deep, and durable responses in heavily pretreated patients with multiple myeloma.

MEDI2228, an ADC that targets the extracellular domain of human BCMA, demonstrated clinical efficacy at all dose levels in treating patients with relapsed/refractory multiple myeloma.