Belantamab mafodotin

BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. BLENREP, a B‑cell maturation antigen (BCMA)‑directed antibody and microtubule inhibitor conjugate, is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Belantamab mafodotin‑blmf is an antibody‑drug conjugate (ADC). The antibody component is an afucosylated IgG1 directed against BCMA, a protein expressed on normal B lymphocytes and multiple myeloma cells. The small molecule component is mcMMAF, a microtubule inhibitor. Upon binding to BCMA, belantamab mafodotin‑blmf is internalized followed by release of the cytotoxic agent (cys‑mcMMAF) via proteolytic cleavage. The released cys‑mcMMAF intracellularly disrupts the microtubule network, leading to cell cycle arrest and apoptosis. Belantamab mafodotin‑blmf had antitumor activity in multiple myeloma cells and mediated killing of tumor cells through cys‑mcMMAF‑induced apoptosis, as well as by tumor cell lysis through antibody‑dependent cellular cytotoxicity and antibody‑dependent cellular phagocytosis.

• The recommended dosage of BLENREP, in combination with bortezomib and dexamethasone, is 2.5 mg/kg as an intravenous infusion over 30 minutes once every 3 weeks for 8 cycles, followed by BLENREP 2.5 mg/kg every 3 weeks as a single agent. • See Full Prescribing Information for instructions on preparation and administration.

None. None.

Boxed warning (ocular toxicity • blenrep): causes changes in the corneal epithelium resulting in changes in vision, including severe visual impairment, and symptoms such as blurred vision and dry eyes. In the clinical study, corneal ulcers, including cases with infection, also occurred. • Conduct ophthalmic exams at baseline, before each dose, promptly for new or worsening symptoms, and as clinically indicated. • Thrombocytopenia: Monitor complete blood counts at baseline and periodically during treatment. Withhold or reduce the dosage based on severity. • Embryo‑fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to fetus and to use effective contraception.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Ocular Toxicity • Thrombocytopenia The most common adverse reactions (≥20%) with BLENREP in combination with bortezomib and dexamethasone are reduction in best-corrected visual acuity (BCVA), corneal exam findings, blurred vision, dry eye, photophobia, foreign body sensation in eyes, eye irritation, upper respiratory tract infection, hepatotoxicity, eye pain, diarrhea, fatigue, pneumonia, cataract, and COVID-19. The most common Grade 3 or 4 (≥10%) laboratory abnormalities are decreased platelets, decreased lymphocytes, decreased neutrophils, increased gamma-glutamyl transferase, decreased white blood cells, and decreased hemoglobin.

Store vials refrigerated at 36ºF to 46ºF (2ºC to 8ºC).