How it Works

Talquetamab-tgvs, a bispecific G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CD3 T-cell engager, is an antineoplastic agent.

How it’s Administered

Injection

3 mg/1.5 mL (2 mg/mL) in a single-dose vial for subcutaneous injection

40 mg/mL in a single-dose vial for subcutaneous injection

Who Should Take Talquetamab

Talquetamab-tgvs is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

Who Shouldn’t Take Talquetamab

• Pregnant women (causes fetal harm when administered to a pregnant woman)
• Females and males of reproductive potential (verify pregnancy status prior to initiating talquetamab and advise females of reproductive potential to use effective contraception during treatment with talquetamab and for 3 months after the last dose)
• Females who are breastfeeding (there is no information regarding the presence of talquetamab in human milk, the effect on the breastfed child, or the effect on milk production)
• Children (the safety and efficacy of talquetamab have not been established in pediatric patients)
• Patients of 75 years of age of older (clinical studies did not include sufficient numbers of patients 75 years of age or over to determine whether they respond differently from younger patients)

The Most Common Side Effects of Taking Talquetamab Include: 

• Cytokine Release Syndrome
• Neurologic Toxicity Including immune effector cell-associated neurotoxicity syndrome (ICANS)
• Headache
• Encephalopathy
• Sensory neuropathy
• Motor dysfunction
• Musculoskeletal pain
• Fatigue
• Decreased weight
• Pyrexia
• Dysgeusia
• Dry mouth
• Dysphagia
• Stomatitis
• Diarrhea
• Hypotension
• Infections
• Neutropenia
• Thrombocytopenia
• Leukopenia
• Anemia
• Rash
• Maculo-papular rash
• Erythema
• Erythematous rash
• Hepatotoxicity
• Embryo-fetal toxicity (causes fetal harm when administered to a pregnant woman)

Currently Being Tested With 

• Daratumumab
• Daratumumab and Pomalidomide
• Daratumumab, Pomalidomide, and dexamethasone
• Teclistamab
• PD-1 inhibitor

Learn more about treatments in Cure Hub

For more information, go to https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761342s000lbl.pdf

Date last updated: 9/19/23