U.S. FDA approves Roche's lymphoma therapy

[December 26, 2022]  (Reuters) - The U.S. health regulator has approved Roche Holding AG's therapy for treating a type of rare cancer called follicular lymphoma.

The U.S. Food and Drug Administration's approval for Lunsumio was based on an early-to mid-stage study that showed the drug cleared signs of cancer in patients, with most patients responding to the treatment for at least 18 months, the company said late Thursday.

The drug, which will be available in the United States in the coming weeks, is expected to cost nearly $180,000 for a fixed course of eight cycles of treatment, the company told Reuters.

Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer that starts in body's white blood cells called lymphocytes.

The disease often relapses after the initial therapy and typically becomes harder to treat each time it relapses in a patient. In the United States, about 13,000 new cases of rare cancer are estimated to be diagnosed in 2022, according to the company.

A logo of Swiss pharmaceutical company Roche in Rotkreuz, Switzerland, April 12, 2012. REUTERS/Michael Buholzer

The drug, known chemically as mosunetuzumab, can be administered at a hospital's outpatient center, unlike some other follicular lymphoma drugs that require extended hospital stays.

Roche's drug would compete with follicular lymphoma therapies from rivals like German drugmaker Bayer AG's Aliqopa, Novartis AG's Kymriah, and Gilead Sciences' Yescarta.

(Reporting by Pratik Jain and Raghav Mahobe in Bengaluru; Editing by Shailesh Kuber)

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