FDA Authorizes Roche's Lymphoma Treatment

Roche Holding AG's (ROG.S) lymphoma therapy has been authorized by the U.S. Food and Drug Administration.

The FDA's approval for follicular lymphoma therapy, a type of rare cancer, will be accessible to patients across the United States in the coming weeks. The therapy is expected to cost around $180,000 for a cycle of eight treatments.

What is Roche’s new lymphoma therapy?

Lunsumio, chemically known as mosunetuzumab, was authorized for accelerated use after early-to-mid-stage research that revealed its effectiveness in cancer patients, with more than half of the participants answering to the treatment for at least 18 months.

The therapy will be available for patients in hospitals and even outpatient facilities, unlike certain follicular lymphoma drugs that necessitate lengthy hospital visits. The drug is administered at specified doses for eight cycles, with each given every 21 days.

The most common adverse effects experienced by more than 20 percent of the study's participants were cytokine release syndrome, fatigue, headache, and rash.

“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said hematologic oncologist and associate professor at City of Hope and clinical trial investigator for mosunetuzumab Elizabeth Budde, MD, Ph.D. “As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio’s high response rates and fixed duration could change the way advanced follicular lymphoma is treated.”

Roche's new therapy is on the market to challenge German drugmaker Bayer AG's (BAYGn.DE) Aliqopa, Novartis AG's (NOVN.S) Kymriah, and Gilead Sciences' (GILD.O) Yescarta.

How does Lunsumio work?

Lunsumio is targeted at adults with relapsed or refractory follicular lymphoma after at least two prior treatments. The therapy is prescribed by medical professionals and is administered as an infusion into the vein. It should be injected once a week in the first cycle, then once every three weeks for the remaining cycles, for a total of eight cycles. In certain circumstances, the treatment can continue for more cycles, even up to 17 cycles.

Lunsumio, a monoclonal antibody, first attaches to CD20, a B lymphocyte protein, and then to CD3, a T cell protein. Then, Lunsumio works by binding the two CD20 and CD3 proteins, allowing cancer cells to all come together. Once all built together, T cells can help rid cancer cells and dominate the disease.

In the trials, Lunsumio was shown to diminish or even rid the disease in 72 out of 90 patients. Fifty-four patients gained complete remission. According to the study, the median response time was 22.8 months, with 62 percent of the participants continuing to respond for at least 12 months and 57 percent of patients responding after 18 months.

What is follicular lymphoma?

Follicular lymphoma is a type of cancer under the category of non-Hodgkin lymphoma. Cancer builds up when the body produces an abnormal amount of B lymphocytes. Lymphocytes are white blood cells in our bodies that help us battle infections. When you develop lymphoma, the abnormal lymphocytes gather up in the lymph nodes or other organs.

Some symptoms of follicular lymphoma may include swelling in the neck, armpit, or groin. The lymphatic system is vital in our immune system, with tubes that contain a large number of white blood cells that help us against infections. Lymphoma blocks our immune systems from fighting off infections, with white blood cells not working properly.


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