Pfizer’s Mylotarg Reinstated onto the Market after FDA Reapproval

Pfizer’s drug Mylotarg, the world’s first approved antibody-drug conjugate, has been put back onto the market after a seven year absence.

Mylotarg is used to treat acute myeloid leukemia (AML) and works by using a targeted antibody to deliver a toxic charge to cancer cells.

The drug was first approved in 2000 but was withdrawn in 2010 after late-stage data raised safety concerns over fatal toxicity, among other things.

However, new adjustments to lower the dose, alter the schedule and include the drug in combination with chemotherapy in a new patient population, have lead the drug to be reintroduced and reapproved by the FDA.

The new patient population the drug is approved for is acute myeloid leukemia patients whose tumours show the CD33 antigen, and adults and children two years and older with relapsed or refractory CD33-positive AML.

The new approved dose for Mylotarg was based on more clinical trials undertaken with the help of Pfizer and suggested that patients receive Mylotarg 3mg/m2 on days 1, 4 and 7 in conjunction with conventional chemotherapy or chemotherapy alone.  

135 patients were treated with Mylotarg and chemotherapy, using the combination the event-free survival figure was 17.3 months, as opposed to the 9.5 months for patients being treated with chemotherapy alone.

The FDA advisory committee recommended the drug’s reapproval last month. Speaking on the reapproval, Liz Barrett, the Pfizer global President 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.”

This news comes just after Kymriah was approved last week. The market looks set to embark on a change in focus with more emphasis being put onto the discover of CAR-T and other immunotherapies. To keep uptodate with all the latest innovations in the oncology market, register for your free ticket to attend the European Oncology Convention 2018 at ExCeL, London on the 6th & 7th June 2018.

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