Pfizer’s blood cancer drug inotuzumab ozogamicin gets FDA priority review

Pfizer’s blood cancer drug, inotuzumab ozogamicin has secured a priority review designation from the US Food and Drug Administration (FDA).

Inotuzumab ozogamicin has been developed as an anti-CD22 antibody-drug conjugate to treat patients suffering from acute lymphoblastic leukemia (ALL) whether the disease has recurred or in refractory form.

As of now, the blood cancer drug from Pfizer is being evaluated for treatment of adult patients having acute lymphoblastic leukemia (ALL) with the trial covering both the relapsed and refractory B-cell precursor conditions.

Thanks to the priority review designation that has been granted, inotuzumab ozogamicin will be have a fast track FDA review inside a six month period that begins from the date of acceptance of filing. If not for the FDA priority review timeline, the blood cancer drug would have had to wait for 10 months for the FDA review.

The FDA priority review is given to drugs that potentially provide important advances in treatment or may give a treatment option for conditions which do not have adequate therapies. The FDA’s Prescription Drug User Fee Act (PDUFA) goal date for a decision on inotuzumab ozogamicin for acute lymphoblastic leukemia is in August this year.

Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development commenting on the FDA priority review for the Pfizer blood cancer drug said: “ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease.

“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.”

It can be noted that inotuzumab ozogamicin had bagged the FDA’s Breakthrough Therapy designation in October 2015 for acute lymphoblastic leukemia.

Elsewhere in Europe, Pfizer’s blood cancer drug, inotuzumab ozogamicin is being reviewed by the European Medicines Agency (EMA) for the same patient population under the pharma’s Marketing Authorization Application (MAA).

The regulatory submissions of the blood cancer drug to FDA and EMA follow the positive results from the Phase 3 INO-VATE 1022 where inotuzumab ozogamicin was trialed versus standard of care chemotherapy.

Pfizer blood cancer drug met the two independent primary endpoints in the Phase 3 INO-VATE 1022 which were complete response with or without hematologic remission (CR/CRi) and overall survival (OS).

As far as the mechanism of the Pfizer blood cancer drug medication is concerned, inotuzumab ozogamicin is an investigational antibody-drug conjugate. It is made up of a monoclonal antibody that acts on CD22, a cell surface antigen that is behind the presence of almost all the cytotoxic agent linked B-cell tumors.