The Food and Drug Administration (FDA) granted Pfizer priority review status for its investigational leukemia treatment, inotuzumab ozogamicin.
Pfizer is seeking a license for the drug to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Inotuzumab ozogamicin is an experimental antibody-drug conjugate comprised of a monoclonal antibody that targets CD22, which is a cell-surface antigen found on approximately 90 percent of B-cell malignancies, according to Pfizer’s statement.
The application was accepted based on data from a Phase 3 trial where investigators compared the drug to standard-of-care chemotherapy on 326 patients with either form of the aforementioned ALL.
Results from the study indicated inotuzumab ozogamicin was able to produce complete remission by about 81 percent in patients receiving the drug compared to 29.4 percent with the individuals being administered the standard therapy.
Also, the drug yielded median overall survival rates of 7.7 months versus 6.7 months on chemotherapy while the median progression-free survival rate was 5 months compared to 1.8 months.
“ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development in a statement. “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 European Medicines Agency is currently reviewing the drug for the same patient population as well.
Filed Under: Drug Discovery
