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Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.
The FDA also granted priority review for Enhertu for the treatment of patients with HER2-positive metastatic gastric cancer.
FoundationOne Liquid CDx can now be used as a companion diagnostic for therapies to treat advanced ovarian, breast, and non-small cell lung cancer.
The company will discuss with the FDA the possibility of using these preliminary Phase I results as part of its registrational package for the agent.
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.
With the FDA's acceptance of its IND application for the drug, the Boston-headquartered firm will begin studying it in TP53-mutated MDS patients.
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.
The agency has granted priority review to Pfizer's sNDA application and is slated to issue a decision by January 2020.
However, the ClarIDHy trial did meet the primary endpoint of progression-free survival, based on which the firm will submit the drug for FDA approval in Q1 2021.