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Precision Oncology Regulatory News & FDA Approvals

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.