Leukemia Drug Approved in European Union

Teva Pharmaceuticals recently announced that the European Commission has expanded the indication of Trisenox (arsenic trioxide) to patients with acute promyelocytic leukemia.

This is the first chemotherapy-free treatment regimen for patients with acute leukemia, according to a press release from Teva.

Acute promyelocytic leukemia (APL) is a rare, aggressive form of acute myeloid leukemia that affects the bone marrow. Only 5% to 10% of patients with acute myeloid leukemia are diagnosed with the aggressive form that can cause death within hours if untreated.

These patients experience easy bruising, as well as various bleeding events, including pulmonary and intracranial bleeds. These symptoms occur due to leukemic blasts creating anticoagulant factors that cause excessive clotting and a low amount of platelets in the blood.

Trisenox plus retinoic acid has shown a 99% survival rate with a low rate of relapses after 4 or more years of follow-up, Teva reported.

The indication expansion comes after a positive recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency, and makes the Trisenox plus retinoic acid a first-line treatment in newly diagnosed patients.

Included in the study that the indication expansion was based on were 276 patients who either received a treatment regimen with chemotherapy or Trisenox. In the study, 100% of patients taking Trisenox achieved remission, while 97% achieved remission on the chemotherapy regimen.

“This approval by the European Commission is good news for APL patients as we now have access to a cure for an acute leukemia without using chemotherapy. Moreover, this decision is a very positive endorsement by the European Commission, as it was made based solely on published academic research and studies,” said Francesco Lo-Coco, professor of Hematology and head of the Laboratory of Integrated Diagnosis of Oncohematologic Diseases, Department of Biomedicine and Prevention, University of Rome Tor Vergata. “From now on, APL patients with non-high risk disease will have access to this chemotherapy-free regimen of Trisenox plus retinoic acid at diagnosis, which has the potential to increase survival rates while minimizing side effects associated with chemotherapy.”

This indication expansion can increase survival rate, reduce the risk of relapse, and avoid side effects related to chemotherapy, according to Teva.

Trisenox was originally approved in the European Union to treat patients with relapsed or refractory APL, which is characterized by the presence of the PML/(RARα) gene. The drug works by targeting and destroying this fusion protein.

“Teva is committed to providing wider access to high-quality medicines to ensure more people can benefit from the treatments they need,” said Rob Koremans, MD, President & CEO, Teva Global Specialty Medicines. “We’re very pleased by this decision of the European Commission, and we look forward to offering a chemotherapy-free treatment option for all newly diagnosed APL patients.”