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Guidelines updated on use of pralatrexate

The National Comprehensive Cancer Network has added pralatrexate to its guidelines for non-Hodgkin's lymphomas

The National Comprehensive Cancer Network (NCCN) has added pralatrexate (Folotyn) to its guidelines for non-Hodgkin's lymphomas as an option for second-line therapy for relapsed or refractory peripheral T-cell lymphoma.

This follows FDA approval in late September of pralatrexate for the treatment of peripheral T-cell lymphoma. The NCCN guildelines give pralatrexate, which is produced by Allos Therapeutics, as a suggested treatment regime, with a category 2B recommendation for patients who are candidates for high-dose therapy.

Last December the results of a phase II trial showed that 27 per cent of patients experienced either a complete or a partial response. The study was conducted in North America and Europe, and was developed under the FDA Special Protocol Assessment programme.

All participants were heavily pretreated and had received a median of three previous systemic treatment regimens. Eighteen patients (16 per cent) had undergone an autologous stem-cell transplant.

Patients received weekly intravenous infusions of pralatrexate for six or seven weeks, along with vitamin B12 and folic acid supplementation (historically shown to reduce the rate of adverse events associated with pralatrexate). Information on 109 patients was available for analysis.

The lead author, Dr Owen A O'Connor, is director of the lymphoid development and malignancy programme and chief of the lymphoma service at the Herbert Irving Comprehensive Cancer Center at New York-Presbyterian Hospital and Columbia University Medical Center in New York City.

Dr Janet Burns, professor of medicine in the division of haematology, oncology and transplantation at the University of Minnesota, US said at the time: "The data are early, as this is only a phase II trial, but there was a strong enough response to move it forward. But this isn't quite a home run, and Dr O'Connor knows that he will need to combine pralatrexate with other therapies.

"However, it is exciting to see a potential new agent come on the market for peripheral T-cell lymphoma," Burns added. "We are learning more about the genetic signatures of T-cell lymphoma, and hopefully we can begin to develop therapies specific to this lymphoma subtype."

Peripheral T-cell lymphoma is particularly aggressive and challenging to treat.

19th October 2009

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