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The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.
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 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 a Phase II study, the drug demonstrated superiority over investigator's choice of chemotherapy in patients with advanced disease.
The accelerated approval was granted based on data submitted from the Phase I/II LIBRETTO-001 trial.
The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.