US regulators approved a new drug used to treat an aggressive form of lymphoma, Swiss pharmaceutical company Roche announced on Friday.
ADVERTISEMENTColumvi, a novel drug used to help patients with a "hard to treat" form of lymphoma — a type of cancer that begins in the cells of the lymphatic system, has been approved for treatment by US authorities.
The treatment is for "relapsed or refractory diffuse large B-cell lymphoma", which is cancer that either reappears or does not respond to treatment.
"People with diffuse large B-cell lymphoma who have gone through multiple lines of therapy have a poor prognosis and desperately need additional treatment options," said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, in a statement announcing the drug's approval on Friday.
"As an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this aggressive lymphoma is treated, reinforcing our dedication to bringing innovative treatment options to people with critical unmet needs."
While many people with this form of cancer do respond to treatment, those who relapse or don't respond have "poor outcomes", the statement added.
The "accelerated approval" of the drug was based on positive results from a study, the company said.
'Complete remission'
Roughly 43% of patients treated with Columvi had a "complete response", meaning remission, for a median duration of 1.5 years, the Swiss company said.
"Over two-thirds of those who responded continued to respond for at least nine months," Roche added.
Among the 145 patients who received the drug in the study, the most common adverse side effects included cytokine release syndrome (an inflammatory response that can be severe), pain, fatigue and rash.
The drug therapy is chemotherapy-free and is completed in about 8.5 months.
The trials show that Columvi can provide patients with "a chance for complete remission...and that such remissions can potentially be sustained after the end of their treatment," said Krish Patel, director of the Lymphoma Programme at the Swedish Cancer Institute in Seattle and an investigator on the study, in a statement from Roche.
Columvi was also recommended for EU approval by the European Medicines Agency in late April.
The EU agency warned that the drug should only be prescribed "by physicians experienced in the diagnosis and treatment of cancer patients who have access to appropriate medical support to manage severe reactions associated with cytokine release syndrome (CRS)."
An estimated 36,000 people are diagnosed with diffuse large B-cell lymphoma per year in Europe, Roche said.
