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20-11-2018 | FDA | News


First-line peripheral T-cell lymphoma, AML drug use announced

medwireNews: The US Food and Drug Administration (FDA) has approved a first-line treatment for patients with peripheral T-cell lymphoma, while the UK’s National Institute for Health and Care Excellence (NICE) has recommended an agent for treatment-naïve acute myeloid leukemia (AML).

The FDA has expanded the indication for brentuximab vedotin to include patients with systemic anaplastic large cell lymphoma and other forms of peripheral T-cell lymphoma that express CD30 who are undergoing CHOP chemotherapy.

The decision follows approval of the monoclonal antibody for treatment-naïve and relapsed stage III-IV classic Hodgkin lymphoma, including those with a high risk for relapse or progression after stem cell transplantation.


NICE has published guidance recommending the use of gemtuzumab oxogamicin for patients aged 15 years or older with untreated CD33-positive AML.

The agent may be given to patients in the UK who have a cytogenetic test at the start of induction or consolidation therapy indicating the disease has favorable, intermediate, or unknown status, as long as the drug manufacturer provides the agent according to the agreed commercial arrangement.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group