Roche's cancer therapy gets US FDA nod, heating up competition with AbbVie

[June 17, 2023]  By Mariam Sunny and Pratik Jain

(Reuters) - The U.S. Food and Drug Administration (FDA) greenlighted Roche Holding AG's experimental therapy to treat a type of advanced blood cancer, nearly a month after the approval of a rival therapy from AbbVie Inc.

Roche's Columvi, an antibody-based therapy chemically known as glofitamab, was approved to treat diffuse large B-cell lymphoma in adults, who had received at least two prior lines of treatment before their cancer relapsed, the Swiss drugmaker said late on Thursday.

AbbVie Inc and Danish drugmaker Genmab's therapy, epcoritamab, last month became the first approved bispecific antibody-based therapy for the disease that annually affects 150,000 people globally.

The list price of epcoritamab, branded as Epkinly, is $37,500 per month. It has an average therapy duration of around nine months, followed by infrequent dosing thereafter.

Roche's Columvi, a fixed-duration treatment completed in about 8.5 months, is expected to cost about $350,000 for the full course and would be available in the United States in the coming weeks, the company said in an emailed response.

The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland January 30, 2020. REUTERS/Arnd Wiegmann/File Photo

Shares of Roche listed on the Swiss stock exchange rose 1.8% to 280.35 CHF ($314.61).

Both Columvi and Epkinly belong to a class of therapies called bispecific antibodies that are designed to bring a cancer cell and an immune cell together so the body's immune system can kill the cancer.

Columvi's approval is based on data from a mid-stage study that showed that 56% of patients treated with the therapy had no signs of cancer or had seen a significant decrease in cancer cells in the body.

($1 = 0.8911 Swiss francs)

(Reporting by Mariam Sunny and Pratik Jain in Bengaluru; Editing by Shinjini Ganguli)

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