By Christy Santhosh and Unnamalai L
(Reuters) -The U.S. Food and Drug Administration has approved Bristol Myers (NYSE:) Squibb’s combination therapy for the treatment of colorectal cancer in patients with a specific gene mutation, the health regulator said on Friday.
The approval under the agency’s accelerated process was based on an early- to mid-stage study in which 94 previously treated patients were given the oral drug Krazati, in combination with cetuximab.
About 34% of patients who received the combination treatment had a partial or complete response during the study. The combination also extended the time patients lived without the disease getting worse by 6.9 months.
Colorectal cancer is the third most common cancer worldwide, accounting for approximately 10% of all cancer cases. According to the World Health Organization, it is the second leading cause of cancer-related deaths worldwide.
Bristol Myers added Krazati to its portfolio after completing its $5.8 billion acquisition of Mirati Therapeutics (NASDAQ:) in January.
Krazati works by targeting a mutated form of the gene known as KRAS, which occurs in 3% to 5% of colorectal cancers. It targets specific gene mutations that increase the number of cancer cells, regardless of the organ in which the disease originated.
“The approval helps justify Bristol’s decision to buy Mirati,” said Morningstar analyst Damien Conover. He estimates that Krazati has annual sales of just over a billion dollars.
Bristol recorded $21 million in U.S. sales of Krazati for the quarter ended March 31, 2024.
The FDA’s decision adds to Bristol’s aim to diversify its oncology business as the company faces pressure from falling demand for two of its top drugs: the blood cancer treatment Revlimid and the blood thinner Eliquis, which face generic competition.
Krazati had received accelerated approval from the FDA in 2022 for the treatment of a type of advanced lung cancer involving the mutated form of the gene known as KRAS.
