Industry Trend Analysis - Mylotarg's Return Will Provide Slight Boost To Pfizer - SEPT 2017
BMI View: Pfizer ' s rebound with the withdrawn Mylotarg will provide a boost to near-term revenues, but it will not be a significant revenue generator for the company. It does highlight that the accelerated approval pathway can bring drugs to market before the ideal patient population is discovered. With the FDA aiming to expedite drug approvals even more, it is likely that further drugs will fail their confirmatory trials.
Pfizer's Mylotarg (gemtuzumab ozogamicin) is making a resounding comeback after being withdrawn from the market in 2010 following an accelerated approval in 2000. The FDA's Oncologic Drug Advisory Committee (ODAC) voted that the results of ALFA-0701 demonstrated a favourable risk:benefit profile for Mylotarg 3mg/m 2 on days one, four and seven added to chemotherapy for patients with newly diagnosed CD33-positive acute myeloid leukaemia (AML). The decision on whether or not to approve the Mylotarg application is anticipated by September 2017.
Comeback Follows Accelerated Approval Failure