(Reuters) – The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s combination therapy for treating colorectal cancer in patients with a specific gene mutation, the health regulator’s website showed on Friday.
The latest approval was based on an early- to mid-stage study in which 94 previously treated patients were administered Bristol’s oral drug, Krazati, in combination with cetuximab.
About 34% of the patients who were given the treatment showed a partial or complete response to it during the study. The Krazati-and-cetuximab combination also helped increase the time patients lived without the disease worsening by 6.9 months.
Bristol Myers added Krazati to its portfolio after it completed an up to $5.8 billion acquisition of Mirati Therapeutics in January.
The drug had previously received accelerated approval from the FDA in 2022 for the treatment of a type of advanced lung cancer with the mutated form of a gene known as KRAS.
Colorectal cancer is the third most common cancer worldwide, accounting for about 10% of all cancer cases. It is the second leading cause of cancer-related deaths worldwide, according to the World Health Organization.
(Reporting by Christy Santhosh, Unnamalai L and Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar and Pooja Desai)
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