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Colorectal cancer is the third most common type of cancer in men and the second most common type of cancer in women in the world.
about 1.8 million new cases in 2018.
BRAF gene mutations occur in about 15% of mCRC, and these patients have a particularly poor prognosis.
v600 mutation is the most common BRAF gene mutation, and patients with BRAF V600E mutations are twice as likely to die as those with wild BRAF genes.
currently not specific to mCRC patients with the BRAF gene mutation.
these patients are still in high unfinished demand.
Braftovi is an oral BRAF inhibitor developed by Array Biopharma.
Pfizer bought Array for $11.4 billion in June.
in the completed Phase 3 clinical trial BEACON CRC, the combination of Braftovi and Erbitux significantly increased the patient's total lifetime (OS) and objective remission rate (ORR) compared to the control group consisting of Erbitux and chemotherapy.
the median OS for braftovi/Erbitux combination therapy was 9.4 months and the control group was 5.4 months (p.0003).
the median ORR for the Braftovi/Erbitux combination therapy was 20%, significantly better than 2% in the control group (p.lt;0.0001).
"The FDA's acceptance of our application for Braftovi combination therapy is encouraging news for mCRC patients with BRAF V600E mutations," said Dr. Chris Boshoff, Chief Development Officer, Pfizer Global Product Development Oncology, who has not been approved for specific treatments.
" In BEACON CRC, the Braftovi/Mektovi/Erbitux triple combination also showed good results.
Pfizer will continue to explore the efficacy of Braftovi dual and triple combination therapy, a first-line treatment for mCRC patients with a mutation in the BRAF gene.
Source: U.S. FDA s and Grants Priority Review to sNDA for BRAFTOVI ® (encorafenib) in Combination with ERERBITUX ® (BRAFTODoublevi) for the Treatment of BRAFVV600E-Metrch Retrieved DIA 18, 2019, from the 2nd BEACON CRC: A Random, 3-Arm, Phase 3 of Encorafenib and Ceximab Without Binimetinib vs. Choice of Either Irinotecan or FOLFIRI, Retrieved D.C. 18, 2019, from the original title: Express. The Pfizer BRAF/EGFR inhibitor portfolio has been given priority review and is expected to change the treatment model for colorectal cancer.
