Pfizer: FDA approves cancer treatment

(CercleFinance.com) - The U.
S. FDA approves Pfizer's BRAFTOVI® combination regimen as a first-line treatment for BRAF V600E-mutated metastatic colorectal cancer.

The indication was approved on the basis of a statistically significant and clinically meaningful improvement in response rate and durability of response in treatment-naive patients treated with BRAFTOVI in combination with cetuximab and mFOLFOX6 from the phase 3 BREAKWATER trial.

Continued approval for this indication is subject to verification of clinical benefit.

This accelerated approval is one of the industry's first to be conducted under the FDA's FrontRunner project, which aims to support the development and approval of new cancer drugs for advanced or metastatic disease.

' Historically, treatment options have been limited and outcomes poor for patients diagnosed with metastatic colorectal cancer with BRAF mutations,' said Scott Kopetz, M.D., Ph.D., FACP, professor and vice chair of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center.

As the first and only BRAF-targeted combination regimen for this patient population that can be used even as first-line therapy, the encorafenib-based regimen has demonstrated high, rapid and durable response rates. This represents an encouraging sign in the continuing fight against the disease, and a source of renewed hope for patients'.

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