FDA Accepts Application for Experimental Leukemia Drug
The FDA has accepted Pfizer’s biologics license application (BLA) and granted priority review for their experimental leukemia treatment.
The FDA has accepted Pfizer’s biologics license application (BLA) and granted priority review for their experimental leukemia treatment. The drug, inotuzumab ozogamicin, is being evaluated as a treatment for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Inotuzumab ozogamicin is an investigational antibody-drug conjugate comprised of a monoclonoal antibody targeting CD22 linked to a cytotoxic agent. The most common adverse events observed in clinical trials included cytopenias, nausea, headache, and pyrexia.
Pfizer’s submission of its BLA is based on results from the phase 3 INO-VATE 1022 trial that compared inotuzumab ozogamicin to standard of care chemotherapy. The study had 2 independent primary endpoints, complete response with or without hematologic remission and overall survival.
“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, Oncology, 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 drug had previously received breakthrough therapy designation from the FDA in October 2015 for ALL. The FDA’s goal date for approval decision is August 2017.
Pfizer announces acceptance of regulatory submission for inotuzumab ozogamicin by the US Food and Drug Administration [news release]. Pfizer’s website. http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_acceptance_of_regulatory_submission_for_inotuzumab_ozogamicin_by_the_u_s_food_and_drug_administration. Feb. 21, 2017.