Tecvayli

Multiple myeloma — relapsed or refractory, after at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Step-up dosing: Day 1: 0.06 mg/kg SC; Day 4: 0.3 mg/kg SC; Day 7 and weekly thereafter: 1.5 mg/kg SC
Subcutaneous injection in abdominal wall
Pre-medication (1-3 hours before step-up and first full dose): Dexamethasone 16 mg IV or PO, acetaminophen 650-1000 mg PO, diphenhydramine 25-50 mg PO or IV
Monitoring: Hospitalize for 48 hours after each step-up dose

Injection: 10 mg/mL in 1.5 mL (15 mg) and 15.3 mg/mL in 10 mL (153 mg) single-dose vials

None listed.

• CRS: 72% (0.6% Grade ≥3). Almost all limited to step-up phase. Median onset: 2 days after first step-up dose.
• Neurologic Toxicity: 57% (4% Grade ≥3). Including headache, motor dysfunction, sensory neuropathy, encephalopathy, cranial nerve palsies.
• Infections: 76% (45% Grade ≥3). Including COVID-19, pneumonia, sepsis. Fatal infections reported. Monitor for signs of infection.
• Cytopenias: Neutropenia 71% (64% Grade 3-4), anemia 52% (37% Grade 3-4), lymphopenia 92% (87% Grade 3-4). Monitor CBC.
• Hypogammaglobulinemia: 79%. Monitor immunoglobulin levels. Consider IVIG supplementation.
• Hepatotoxicity: 15% (4% Grade ≥3). Monitor LFTs.

Infections (76%), CRS (72%), fatigue (46%), musculoskeletal pain (36%), injection site reactions (33%), nausea (24%), pyrexia (23%), headache (21%), hemorrhage (20%), diarrhea (17%), neutropenia (71%), anemia (52%), lymphopenia (92%)

CRS in 72% (Grade 3+ in 1%). ICANS in 5% (Grade 3+ in 3%). Serious infections in 22% (including fatal). Hepatotoxicity (Grade 3+ in 5%). Grade 3+ cytopenia: neutropenia 64%, anemia 37%, thrombocytopenia 21%.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

CRS in 72% (Grade 3+ in 1%). ICANS in 5% (Grade 3+ in 3%). Serious infections in 22% (including fatal). Hepatotoxicity (Grade 3+ in 5%). Grade 3+ cytopenia: neutropenia 64%, anemia 37%, thrombocytopenia 21%.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Teclistamab is a bispecific humanized IgG4 monoclonal antibody that binds to B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells. By simultaneously binding both targets, it redirects T cells to BCMA-expressing myeloma cells, inducing T-cell activation, cytokine release, and T-cell mediated killing of myeloma cells.

Half-life: approximately 5.5 days at target dose. Steady-state by Cycle 3. Non-linear PK during step-up. Step-up dosing reduces CRS incidence. Clearance: 0.6 L/day.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• MajesTEC-1 — Teclistamab in relapsed/refractory multiple myeloma. Phase I/II.
  🔬 NCT03145181 ↗ 📄 Primary Publication ↗

Tecvayli has FDA-approved indications across the following cancer types covered on PipelineEvidence: