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The results of the randomized Phase III ADAURA trial was unblinded early due to "overwhelming efficacy" in lung cancer patients.
ArcherDx will develop sequencing-based circulating tumor DNA assays for use in AstraZeneca's recently launched Phase III MERMAID-1 trial of durvalumab (Imfinzi).
The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The agency granted breakthrough therapy designation to the antibody-drug conjugate based on data from the ongoing Phase II DESTINY-Lung01 trial.
The survival data from the Phase III SOLO2 trial confirms to experts that olaparib should be the standard of care maintenance therapy for patients in this setting.
The guideline, in effect for three months, gives access to many molecularly informed indications that NICE previously found not cost-effective or that it hasn't yet reviewed.
In a Phase II study, the drug demonstrated superiority over investigator's choice of chemotherapy in patients with advanced disease.
The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
Though the Phase II results from the I-SPY 2 trial showed a potential benefit of the regimen in the neoadjuvant setting, additional data are needed.
Merck and AstraZeneca's PARP inhibitor was reported previously to stave off disease progression, based on which supplemental new drug application was filed with the FDA.