Pfizer’s colorectal cancer drug gains momentum with promising data

USA – Pfizer recently received accelerated approval from the FDA for its combination therapy based on Braftovi (encorafenib) to treat colorectal cancer, and new survival data may soon lead to full approval.

The combination therapy includes Braftovi, Eli Lilly’s Erbitux (cetuximab), and chemotherapy, specifically targeting patients with BRAF V600E-mutated metastatic colorectal cancer.

Results from the BREAKWATER study revealed that this combination significantly improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone or chemotherapy with bevacizumab.

Pfizer described these improvements as “clinically meaningful.” Roger Dansey, Pfizer’s chief oncology officer, stated, “The Braftovi regimen has the potential to be practice-changing for this patient population that has historically had limited treatment options and poor outcomes.”

The therapy initially received FDA approval based on an objective response rate (ORR) of 61%, compared to 40% in the control group.

This data, presented at the ASCO GI congress and published in Nature Medicine, supported the approval under the FDA’s new Project FrontRunner initiative.

Project FrontRunner aims to expedite the approval process for cancer treatments by allowing single clinical trials to form the basis for review.

This combination therapy is a significant milestone, as it is the first BRAF-targeted regimen approved for first-line treatment of colorectal cancer with BRAF V600E mutations.

Though this mutation occurs in only 8%–10% of metastatic colorectal cancer cases, it is known for its aggressiveness, making these advances particularly valuable for affected patients.

Braftovi has already been approved for other indications, including unresectable or metastatic BRAF-positive melanoma and non-small cell lung cancer (NSCLC).

It is also authorized for second-line treatment of BRAF-positive colorectal cancer in combination with Erbitux. Pfizer acquired the drug through its US $11.4 billion acquisition of Array Biopharma in 2019.

With sales of US $437 million in the first nine months of 2024, Braftovi has become a mid-range product for Pfizer.

Analysts believe its use in NSCLC and the expanded colorectal cancer indication could boost sales beyond US $1 billion annually.

The new overall survival data may encourage more widespread use of the therapy, provided physicians increase testing for BRAF mutations in colorectal cancer patients.