The approval will make Merck and AstraZeneca's Lynparza available to patients in the EU who have not progressed after 16 weeks on platinum-based chemotherapy.
Researchers reported a correlation between ctDNA clearance and progression-free survival in EGFR-positive, MET-amplified patients treated with Tagrisso and savolitinib.
With studies showing BRCA-mutated patients have a greater magnitude of benefit, oncologists grapple with complex treatment decisions in BRCA mutation-free cases.
The Phase II DESTINY-CRC01 and DESTINY-Gastric01 underscore the importance of HER2 testing in patients with colorectal cancers and gastric cancers, respectively.
The agency based its decision on the results of the POLO trial, in which patients on olaparib had a median progression-free survival of 7.4 months compared to 3.8 months on placebo.
The studies highlighted the activity of three drugs in NSCLC patients characterized by HER2 mutations, CECAM5 overexpression, and high PD-L1 expression.
ArcherDx will develop sequencing-based circulating tumor DNA assays for use in AstraZeneca's recently launched Phase III MERMAID-1 trial of durvalumab (Imfinzi).
