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Qiagen and Foundation Medicine will develop tissue- and plasma-based companion tests to identify best responders to the PI3K inhibitor alpelisib
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments.
Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.
The recent failure of Bristol-Myers Squibb's lung cancer immunotherapy to meet its primary endpoint demonstrates the challenge of working with imperfect biomarkers.
Dako developed the PD-L1 CDx very specifically to fit Keytruda's mechanism and patients' outcomes to the drug.