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.

Pages

Recommended Reading

Esketamine gets the green light for depression
MDedge Hematology and Oncology
Ready for universal hepatitis C testing?
MDedge Hematology and Oncology
Autism risk with in utero infections
MDedge Hematology and Oncology
Aspirin and lower risk of COPD flare-up
MDedge Hematology and Oncology
Treating lymphoma in patients with HIV
MDedge Hematology and Oncology
Semaglutide plus SGLT2 inhibitors for type 2 diabetes
MDedge Hematology and Oncology
Bempedoic acid: funny name, serious LDL lowering
MDedge Hematology and Oncology
First primary prevention CVD guidelines form ACC, AHA
MDedge Hematology and Oncology
Genetic signature helps ID MS risk
MDedge Hematology and Oncology
Anastrozole-fulvestrant in breast cancer and daily aspirin to prevent HCC
MDedge Hematology and Oncology