This is the second precision oncology drug approved by the agency for patients with RET-mutant medullary thyroid cancer or RET fusion-positive thyroid cancer.
The regulatory submission triggers a milestone payment, and Invitae will issue 5 million shares of its common stock to former ArcherDx securityholders.
The agency recommended the combination for previously untreated CLL patients with certain genetic mutations, including those with a 17p deletion or TP53 mutation.
The test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer.
Though Guardant and Foundation have pioneered a path through the FDA for liquid biopsy tests, label differences highlight complex choices for oncologists.
The test analyzes substitutions, insertion and deletion alterations, and copy number alterations in 324 genes, along with some genomic signatures in solid tumors.
Although pandemic-related manufacturing delays impacted the NDA filing, the company remains on track to file its PMA for the companion diagnostic by year end.
The company will seek FDA approval in advanced systemic mastocytosis, a disorder that can turn into cancer in 7 percent of children and 30 percent of adults.
