Following a positive recommendation in April from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission has approved US pharma giant Pfizer’s (NYSE: PFE) Besponsa(inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
This indication includes treatment of adults with Philadelphia chromosome positive (Ph+) as well as Philadelphia chromosome negative (Ph-) relapsed or refractory B-cell precursor ALL. Adults with Ph+ relapsed or refractory CD22-positive B-cell precursor ALL should have failed treatment with at least one tyrosine kinase inhibitor (TKI). With this approval, BESPONSA becomes the first and only antibody drug conjugate (ADC) available for patients with this type of leukemia in the European Union (EU).
In 2013, inotuzumab ozogamicin was effectively dumped by Pfizer after a failed Phase III study in non-Hodgkin lymphoma (NHL) but was later brought back to life.
“The European Commission’s approval of Besponsa represents an important milestone for patients, the oncology community and Pfizer,” said Andreas Penk, regional president, Pfizer Oncology. “This is the first approval for Besponsa and provides patients in the EU, who are battling an especially hard-to-treat leukemia, with a new treatment option beyond chemotherapy,” he added.
The European Commission’s approval of Besponsa is supported by results from the Phase III INO-VATE ALL trial, in which 326 adult patients with relapsed or refractory B-cell precursor ALL were enrolled and which compared Besponsa to standard of care chemotherapy. The INO-VATE ALL study had two primary endpoints, complete response with or without hematologic recovery (CR/CRi) and overall survival (OS). Results from the trial were published in The New England Journal of Medicine in June 2016.
In the USA, Besponsareceived Breakthrough Therapy designation from the Food and Drug Administration in October 2015 for ALL. A Biologics License Application (BLA) for Besponsa for the treatment of adult patients with relapsed or refractory B-cell precursor ALL was accepted for filing and granted Priority Review by the FDA in March 2017. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is August 2017.