A diagnostics subsidiary of Swiss drugmaker Roche has filed for approval of its liquid biopsy test and anticipates a Food and Drug Administration ruling in the first half of this year.
In an interview at the J.P. Morgan Healthcare Conference in San Francisco, Foundation Medicine CEO Cindy Perettie said the company filed for FDA approval of the FoundationOne Liquid test at the end of December. The approval would include companion diagnostics claims, as well as claims for microsatellite instability and blood tumor mutation burden. The company anticipates that the test would be covered under the National Coverage Determination for next-generation sequencing, rather than there being a need to obtain a new NCD. The company applied for approval in parallel with its biopharma partners, though Perettie declined to name them.
In October, the company presented data from the Phase II/III BFAST study – which is enrolling 580 patients with non-small cell lung cancer – on people receiving Roche’s drug Alecensa (alectinib), a drug that targets ALK fusions, a genetic driver of NSCLC. Among 2,219 screened and 2,188 whose tests yielded blood-based next-generation sequencing results, 5.8% were found to have ALK fusions. The overall response rate for patients in the study who received Alecensa was 87.4%, which investigators wrote resulted in a high response rate and clinical benefit among patients receiving the drug and validated liquid biopsy’s clinical utility in ALK fusion-positive NSCLC.
“Having that concordance gives us a lot of confidence,” Perettie said, referring to the ability of liquid biopsy to detect mutations at a rate comparable to what has been found before.
Although BFAST was not specifically designed to show head-to-head concordance with tissue biopsy, research has indicated that ALK fusions are present in 4-6% of NSCLC cases.
The study is also enrolling patients who receive Rozlytrek (entrectinib), an inhibitor of NTRK fusions, which are also genetic drivers of cancers, among other drugs.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Concordance is a crucial consideration with liquid biopsy because, while significantly less cumbersome than tissue biopsy, it of course would defeat the purpose of using liquid biopsy if patients who have undergone it nevertheless must still undergo tissue biopsy as well.
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