News from the FDA/CDC

2018 at a glance: Recently approved therapies in oncology


Mogamulizumab (Poteligeo)

Class: Monoclonal antibody that binds to a protein (CC chemokine receptor type 4).

Disease: Relapsed or refractory mycosis fungoides or Sézary syndrome.

Dose: Intravenous infusion 1 mg/kg.

AE: Dermatologic toxicity.

MAVORIC trial (NCT01728805): Patients who received mogamulizumab had improved progression-free survival (median 7.7 months), compared with those taking vorinostat (median 3.1 months).

Moxetumomab pasudotox-tdfk (Lumoxiti)

Class: CD22-directed cytotoxin fused with a fragment of Pseudomonas exotoxin A.

Disease: Relapsed or refractory hairy cell leukemia previously treated with at least two prior systemic therapies, including a purine nucleoside analogue.

Dose: Intravenously as 0.04 mg/kg.

AE: Hemolytic uremic syndrome.

1053 trial (NCT01829711): 30% of the patients who received moxetumomab pasudotox-tdfk had a durable complete response confirmed by maintenance hematologic remission.

Talazoparib (Talzenna)

Class: Poly (ADP-ribose) polymerase (PARP) inhibitor.

Disease: gBRCAm HER2-negative locally advanced or metastatic breast cancer.

Dose: 1 mg orally per day.

EMBRACA trial (NCT01945775): Patients who received talazoparib demonstrated significantly longer progression-free survival, with a median of 8.6 months versis 5.6 months in the control arm.

Dr. Bryer is a resident in the department of internal medicine at the University of Pennsylvania, Philadelphia. Dr. Mentzer is chief of hematology-oncology at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania. Dr. Henry is a hematologist-oncologist at Pennsylvania Hospital and a professor of medicine at the University of Pennsylvania.

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