Pfizer To Discontinue Mylotarg In US

Pfizer received approval for the single agent Mylotarg, in the US, under FDA’s accelerated approval regulations based on overall response rate in three non-comparative studies and required submission of additional data to confirm clinical benefit.

The required post-approval study (SWOG S0106) combining chemotherapy and Mylotarg did not demonstrate improved survival compared with chemotherapy alone in patients with previously untreated AML.

Additionally, among all patients evaluable for early toxicity the fatal induction toxicity rate was higher in subjects given the combination of standard induction chemotherapy and Mylotarg than in those treated with chemotherapy alone.

Mace Rothenberg, senior vice president of clinical development and medical affairs for oncology business unit of Pfizer, said: “We are disappointed that the study did not confirm the clinical benefit of Mylotarg.”

Pfizer advised that the patients, who are currently taking Mylotarg and those patients who have been prescribed Mylotarg, may continue their course of therapy, in consultation with their physicians.

Pfizer recommended not to prescribe Mylotarg to new patients in the US and that future use of Mylotarg for new patients in the US is expected to require physician submission of an investigational new drug (IND) application to the FDA.

Pfizer is also working with Health Authorities outside the US and any actions and appropriate next steps taken by FDA for Mylotarg will be informed to the patients, regulatory authorities, investigators and clinicians.