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FDA grants priority review to inotuzumab ozogamicin for ALL
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The FDA granted priority review to inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, according to the drug’s manufacturer.
Inotuzumab ozogamicin (CMC-544, Pfizer) is an investigational antibody–drug conjugate comprised of a monoclonal antibody that targets CD22 — a cell surface antigen expressed on approximately 90% of B-cell malignancies — linked to the cytotoxic agent calicheamicin.
Pfizer’s biologics license application included results from the phase 3 INO-VATE 1022 trial, designed to compare inotuzumab ozogamicin with standard-of-care chemotherapy in 326 adults with relapsed or refractory B-cell ALL.
Complete remission — including complete remission with incomplete hematologic recovery — and OS served as the coprimary endpoints.
The results, published last summer in The New England Journal of Medicine, showed patients treated with inotuzumab ozogamicin were more likely to achieve complete remission and disease levels below the threshold for minimal residual disease. Inotuzumab ozogamicin also was associated with longer PFS and OS.
The FDA is expected to make a decision by August.
“ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer Global Product Development, said in a press release. “Based on the positive results of the INO-VATE 1022 phase 3 trial, we believe inotuzumab ozogamicin — if approved — represents a new treatment option for adult patients with relapsed or refractory B-cell precursor ALL.”
The FDA granted breakthrough therapy designation to inotuzumab ozogamicin for the treatment of ALL.