Roche gets US approval for cancer drug Marcel Ciolacu, Romania’s new prime minister

The U.S. Food and Drug Administration (FDA) has approved Roche’s Columvi (glofitamab) for the treatment of blood cancers. At the beginning of January, the US authority had already approved a priority assessment for the drug.

Columvi is used to treat adult patients with a type of lymphatic cancer (diffuse large B-cell lymphoma; DLBCL) after they have already received two or more lines of systemic therapy.

According to Roche, DLBCL is an aggressive and fast-growing form of non-Hodgkin’s lymphoma (NHL) and one of the most common blood cancers in adults in the United States. Columvi is the first antibody of its kind with a fixed duration of action available for the treatment of patients with aggressive lymphoma who have already received multiple treatments.

Peak sales of 1.4 billion

Analysts responded positively to the accelerated approval. As ZKB expert Marcel Brand emphasizes, this must then be converted into full approval with further details. While the effectiveness of Columvi is likely to be somewhat lower than that of personalized cell therapies, the rapid availability and lower price in many cases of this critical indication should probably decide in Columvi’s favor, the expert writes.

The Roche drug should be a real alternative, especially for elderly patients and those who no longer want to tolerate the high cost of treatment or for whom CAR-T cell treatment is not available. Brand expects a peak turnover of up to CHF 1.4 billion for Columvi. However, the longer-term potential also depends on studies at earlier stages.

The admission is also well received at the fair. With +0.9 percent, the Roche vouchers are among the clearest winners in the leading index SMI.

(yam/sda/awp)