US FDA approves Bristol Myers' colorectal cancer therapy
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[June 22, 2024]
By Christy Santhosh and Unnamalai L
(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 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
administered the oral drug Krazati, in combination with cetuximab.
About 34% of the patients who were given the combination treatment
showed a partial or complete response to it during the study. The
combination also helped increase the time patients lived without the
disease worsening by 6.9 months.
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.
Bristol Myers added Krazati to its portfolio after it completed its up
to $5.8 billion acquisition of Mirati Therapeutics in January.
Krazati works by targeting a mutated form of the gene known as KRAS that
occurs in 3% to 5% of colorectal cancers. It targets specific gene
mutations that drive cancer cell count up regardless of the organ in
which the disease originated.
"The approval helps justify Bristol's decision to buy Mirati,"
Morningstar analyst Damien Conover said. He estimates just over a
billion dollars in annual sales for Krazati.
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![](../images/062224PIX/health84.jpg)
A sign stands outside a Bristol Myers Squibb facility in Cambridge,
Massachusetts, U.S., May 20, 2021. REUTERS/Brian Snyder/File Photo
![](http://archives.lincolndailynews.com/2024/Jun/22/images/ads/current/graue_lda_preowned_061024.jpg) Bristol recorded $21 million in U.S.
sales of Krazati for the quarter ended March 31, 2024.
The FDA's decision adds on to Bristol's goal to diversify its
oncology business as the company faces pressure from declining
demand for two of its top drugs — the blood cancer treatment
Revlimid and 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 with the mutated
form of the gene known as KRAS.
(Reporting by Christy Santhosh, Unnamalai L and Puyaan Singh in
Bengaluru; Editing by Pooja Desai and Shilpi Majumdar)
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