After the recent FDA Oncologic Drugs Advisory Committee (ODAC) Hearing’s 12-0 vote recommending approval of belantamab mafodotin, it was expected that the FDA would quickly follow suit and proceed with accelerated approval which happened today (See press release link below). This first-in-class anti-B-cell maturation antigen, monoclonal antibody — a drug conjugate — provides an important option for patients who have received at least 4 prior therapies. The overall response rate for these patients was 31%, with 73% of these patients having responses for 6 months or more.
There has been concern about eye toxicities with irritation of the cornea, requiring regular eye checkups for indications that a dose modification is needed. A formal Risk Evaluation and Mitigation Strategy (REMS) is still required. Yet, it is excellent to have this valuable new option available.