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News on molecular markers used to guide cancer treatment, assess prognosis, or detect relapse.
The latest approval is immunotherapy Tecentriq's fourth indication in non-small cell lung cancer and fifth indication in lung cancer.
The agency granted breakthrough therapy designation to the antibody-drug conjugate based on data from the ongoing Phase II DESTINY-Lung01 trial.
This approval, based on the part 1a results from the Phase III CheckMate-227 trial, is the fifth indication for this drug combination.
The accelerated approval was based on data from the TRITON2 trial involving metastatic patients with BRCA mutations and homologous recombination deficiency.
In KEYNOTE-355, patients with PD-L1 expression greater than or equal to a combined positive score of 10 had improved progression-free survival on first-line Keytruda and chemo.
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.
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.
The firm can now market the drug to Chinese patients with early-stage HER2-positive breast cancer.
The company submitted a supplemental NDA for the antibody drug conjugate based on objective response and overall survival data from the Phase II DESTINY-Gastric01 trial.