GlaxoSmithKline gets accelerated OK of chemotherapy Arranon

By E. Janene Geiss

Philadelphia, Oct. 28 - GlaxoSmithKline announced Friday that the U.S. Food and Drug Administration has approved chemotherapy agent Arranon injection for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded or relapsed after treatment with at least two chemotherapy regimens.

Approximately 1,600 adults and children are diagnosed with T-ALL or T-LBL in the U.S. each year. A subset of these patients will relapse or develop disease that is refractory to treatment. There is no standard of treatment for these patients and their prognosis is particularly poor, according to a company news release.

To facilitate the development of Arranon for this relatively small group of patients, GlaxoSmithKline worked closely with the National Cancer Institute of the National Institutes of Health, the Children's Oncology Group and the Cancer and Leukemia Group B, in conjunction with the Southwest Oncology Group, officials said.

Arranon received accelerated approval, granted by the FDA to medicines for treating serious or life-threatening illnesses for patients who had exhausted standard treatment options, officials said.

"Arranon represents new hope for adults and children suffering from these rare and deadly cancers," Kevin Lokay, GlaxoSmithKline's vice president of Oncology and Acute Care, said in the release.

More than 980 patients have received Arranon as part of clinical trial protocols. The two multi-center pivotal phase II clinical trials included a total of 39 adults and 151 children with T-ALL or T-LBL.

The primary efficacy results were based on 28 adults and 39 children that had multiple relapses following at least two prior induction regimens.

In these groups, a total of 21%of adults and 23% of children achieved a complete response or a complete response without full hematological recovery with single agent Arranon.

Remissions were generally long enough to allow for stem cell transplant procedure, often the intent following successful induction of remission.

Following Arranon, patients had a median overall survival of 21 weeks for adults and 13 weeks for children.

Pharmaceutical company GlaxoSmithKline is based in London.

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