Roche blood cancer drug Columvi gets EMA panel recommendation for EU approval

“New therapeutic options that are readily and broadly available are urgently needed for people with relapsing diffuse large B-cell lymphoma, which can become fatal without immediate treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The CHMP’s recommendation for Columvi brings us closer to providing a new, fixed-duration therapy for people with diffuse large B-cell lymphoma that induces early and long-lasting responses.”

DLBCL is an aggressive (fast-growing) type of lymphoma and is one of the most prevalent types of blood cancer among adults. Each year in Europe, an estimated 36,000 people are diagnosed with DLBCL. While many people with DLBCL are responsive to initial treatment, four out of ten are not cured with the current frontline standard of care, and the majority of those who require subsequent lines of therapy have poor outcomes.

Additional data from a larger cohort in the NP30179 study, published in the New England Journal of Medicine, reinforce the durability of Columvi. Fixed-duration Columvi resulted in early and long-lasting responses in people with heavily pre-treated or refractory DLBCL, with 39.4% of patients (n=61/155) achieving a CR and a median DOR of 18.4 months. Median time to first CR was 42 days (95% CI: 42-44), with the majority of responses reported at the first scheduled response assessment (approximately 1.4 months after the start of treatment). Half of patients (51.6%; n=80/155) achieved an OR. 

Columvi was recently approved by Health Canada for the treatment of adult patients with R/R DLBCL not otherwise specified, DLBCL arising from follicular lymphoma, or primary mediastinal B-cell lymphoma, who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR T-cell therapy or have previously received CAR T-cell therapy. Additionally, the U.S. Food and Drug Administration (FDA) accepted Genentech’s Biologics License Application and granted priority review for glofitamab for the treatment of people with R/R large B-cell lymphoma. The U.S. FDA is expected to make a decision on approval by 1 July 2023. Submissions to additional health authorities worldwide are ongoing.

Roche’s portfolio also includes Lunsumio (mosunetuzumab), which was granted accelerated approval by the U.S. FDA in December 2022 and conditional marketing authorisation by the EC in June 2022 for the treatment of adult patients with R/R follicular lymphoma after two or more lines of systemic therapy.

Read also: USFDA nod to Roche's Polivy in combination with R-CHP for certain types of previously untreated diffuse large B-cell lymphoma