Christy Santosh and Unnamalai L.
(Reuters) – The U.S. Food and Drug Administration has approved Bristol Myers’ (NYSE:) Squibb combination therapy to treat 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 Crasati in combination with cetuximab.
About 34% of patients receiving the combination treatment showed a partial or complete response during the study. The combination also helped patients live longer without worsening their disease by 6.9 months.
Colorectal cancer is the third most common cancer in the world, accounting for about 10% of all cancer cases. According to the World Health Organization, it is the second leading cause of cancer deaths in the world.
Bristol Myers added Krazati to its portfolio after completing its acquisition of Mirati Therapeutics (NASDAQ:) in January for up to $5.8 billion.
Crasati works by targeting a mutated form of a gene known as KRAS, which occurs in 3-5% of colorectal cancer cases. It targets specific gene mutations that increase the number of cancer cells regardless of the organ in which the disease originates.
“This approval helps justify Bristol’s decision to buy Mirati,” said Morningstar analyst Damien Conover. He estimates Krazati’s annual sales are just over a billion dollars.
In Bristol, Krazati had U.S. sales of $21 million for the quarter ended March 31, 2024.
The FDA’s decision complements Bristol’s goal to diversify its oncology business as the company faces pressure from declining demand for its two main drugs, the blood cancer drug Revlimid and the blood thinner Eliquis, which face generic competition.
In 2022, Crasati received accelerated approval from the FDA to treat advanced lung cancer with a mutated form of the gene known as KRAS.