Columvi

Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma in adults after ≥2 lines of systemic therapy.

Pretreatment w/ obinutuzumab: Single dose of obinutuzumab 1,000 mg IV infusion on day 1 of cycle 1, administered 7 days prior to initiation of Columvi. Administer obinutuzumab at a rate of 50 mg/hr, can be escalated in increments of 50 mg/hr every 30 min to a max of 400 mg/hr. Columvi dose schedule (21-day treatment cycle): Administer 2.5 mg IV infusion (step-up dose 1) for 4 hr on day 8 of cycle 1, then 10 mg IV infusion (step-up dose 2) for 4 hr on day 15 of cycle 1, followed by 30 mg IV infusion for 4 hr on day 1 of cycle 2 & for 2 hr on day 1 of cycles 3-12. Continue for a max of 12 cycles (inclusive of cycle 1 step-up dosing) or until disease progression or unacceptable toxicity. In case of CRS w/ previous dose, 4-hr duration of infusion may be extended up to 8 hr & 2-hr duration of infusion should be maintained at 4 hr.

Risk of cytokine release syndrome (CRS). Premedicate before each dose w/ dexamethasone or equiv, acetaminophen, & antihistamine (diphenhydramine or equiv). Ensure adequate hydration. Patients should be hospitalized during & for 24 hr after completion of step-up dose 1. Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during & for 24 hr after completion of step-up dose 2. CRS w/ step-up dose 2 can occur in patients who did not experience CRS w/ step-up dose 1. Patients who experienced grade ≥2 CRS w/ previous infusion should be hospitalized during & for 24 hr after completion of subsequent infusions. Risk of neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). Co-administration w/ other products that cause dizziness or mental status changes may increase risk of neurologic toxicity. Monitor for signs & symptoms of neurologic toxicity. Risk of infections. Should not be administered to patients w/ active infection. Monitor for infection before & during treatment. Risk of tumor flare. Patients w/ bulky tumors or disease located in close proximity to airways or vital organ should be monitored closely during initial therapy. Monitor for signs & symptoms of compression or obstruction due to mass effect secondary to tumor flare. Consider tumor lysis syndrome prophylaxis, antiviral prophylaxis, & Pneumocystis jirovecii pneumonia prophylaxis before starting Columvi. W/hold or permanently discontinue based on severity of adverse reactions. May impair ability to drive or operate machinery. May cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment & for 1 mth after the last dose. Women should not breastfeed during treatment & for 1 mth after the last dose. Safety & efficacy in ped patients have not been established.

CRS, musculoskeletal pain, rash, fatigue; decreased lymphocyte count, phosphate, neutrophil count, fibrinogen, increased uric acid.

Increased exposure of CYP substrates.

Targeted Cancer Therapy

L01FX28 - glofitamab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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