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The latest regulatory news and FDA approvals.
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.
The decision is based on data from the PAOLA-1 trial, which focused on patients with tumors that have homologous repair recombination deficiency.
CHMP recommended approval only in patients with BRCA1/2 mutations, while the FDA approved olaparib in those with mutations in additional HRR genes.
The test detects the presence of two biomarkers within a single cell associated with HPV infections that can progress to cervical cancer.