Guardant Health snagged the FDA green light to use its Guardant360 CDx colon cancer diagnostic along with Pfizer’s colon and skin cancer drug Braftovi in combination with cetuximab and chemotherapy.
The blood test was first approved by the regulatory agency in 2023 as a companion diagnostic for Menarini’s SERD breast cancer treatment Orserdu. Cetuximab is marketed by Eli Lilly in the U.S. under the name Erbitux. Merck KGaA has the license to make the treatment outside the country.
Guardant’s test analyzes circulating tumor DNA that is then used to identify patients with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with the Braftovi combo therapy, the company said in a Jan. 22 press release.
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“This latest approval highlights the growing impact of liquid biopsy across advanced cancer care and underscores the utility of Guardant360 CDx in enabling precision therapy selection for patients with diverse, hard-to-treat tumors including aggressive colorectal cancer,” Helmy Eltoukhy, Ph.D., Guardant chair and co-CEO, said in a statement.
“With multiple FDA-cleared companion diagnostic claims across lung and breast cancer, and now colorectal cancer, and the ability to comprehensively profile tumor genomics from a simple blood draw … helping clinicians match patients to the right targeted therapies faster and more effectively.”
The approval was based on results from Pfizer’s phase 3 Breakwater study, presented earlier this year, which found the Braftovi combination cut the risk of death by 51% compared with standard-of-care chemotherapy, with or without Roche’s multi-licensed cancer drug Avastin, the company said.
Patients who took the Braftovi regimen lived for a median of 30.3 months, just over double the 15.1 months for those who received chemotherapy, with or without Avastin.
The Pfizer regime also provided a significant difference in how long patients lived without their disease getting worse, with the Braftovi group experiencing a median 12.8 months of progression-free survival versus the 7.1 months seen in the control arm.
