Roche's blood cancer drug Columvi gets EMA panel nod for EU approval
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- A committee of the European Medicines Agency (EMA) recommended the approval of Roche's (OTCQX:RHHBY) (OTCQX:RHHBF) Columvi (glofitamab) to treat adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
- The positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) was based on data from a group in a phase 1/2 trial, dubbed NP30179.
- The Swiss pharma giant said that Columvi is designed to be given for a fixed period of time and is an off-the-shelf therapy, meaning that people do not have to wait for cell collection and genetic engineering before starting therapy.
- The European Commission (EC), which generally follows the opinion of the CHMP, will now make a final decision on the application.
- Meanwhile, the U.S. FDA is also expected to make a decision on the drug by July 1.
- DLBCL is an fast-growing type of lymphoma and is one of the most prevalent types of blood cancer among adults, according to the company.