Regulatory Affairs

Pfizer gets FDA nod for acute myeloid leukaemia drug Mylotarg

PBR Staff Writer Published 04 September 2017

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Mylotarg (gemtuzumab ozogamicin) to treat adults with newly diagnosed CD33-positive acute myeloid leukemia (AML).

The approval will allow Pfizer to treat adults and children two years and older with relapsed or refractory CD33-positive AML with Mylotarg.

Mylotarg is an antibody-drug conjugate that includes cytotoxic agent calicheamicin. It is attached to a monoclonal antibody (mAB) targeting CD33.

Pfizer and Celltech have collaborated for the development of Mylotarg. Pfizer is responsible for all manufacturing, clinical development and commercialization activities for this molecule.

Under FDA’s accelerated approval program, Mylotarg was first approved in 2000 for use as a single agent in patients with CD33-positive AML who had experienced their first relapse and were 60 years or older and who were not considered candidates for other cytotoxic chemotherapy.

The approval was based on various investigator-led clinical trials, including ALFA-0701, AML-19 and MyloFrance-1.1

ALFA-0701 trial was a phase 3, multicenter, randomized and open-label study of 271 patients with newly-diagnosed de novo AML. It used a new and lower fractionated dose of Mylotarg.

Study AML-19 was a multicenter, randomized and open-label phase 3 study, which compared single agent Mylotarg to best supportive care for elderly patients who could not tolerate other AML therapies.

MyloFrance-1.1 was a Phase 2, single-arm and open-label study of 57 adult patients in first relapse. Patients secured single agent Mylotarg 3mg/m2 on days 1, 4 and 7.

Pfizer Oncology global president Liz Barrett said: “The FDA approval of Mylotarg fills a critical unmet need for many adults and children with AML, which can be fatal in a matter of months or even weeks if not treated and has a high relapse rate.”

Image: Pfizer world Headquarters in Manhattan, New York. Photo: courtesy of Coolcaesar.