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FoundationOne Liquid CDx can now be used as a companion diagnostic for therapies to treat advanced ovarian, breast, and non-small cell lung cancer.
Two new studies show that patients with advanced HR-positive, HER2-negative breast cancer had higher survival when they received combination therapies.
The drugmaker said it is working with centers of excellence in Canada to set up companion diagnostic testing to identify patients with PIK3CA mutations.
The commission took the earlier CHMP recommendation to approve the treatment based on the positive results from the Phase III SOLAR-1 trial.