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regulatory approval

Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.

The drug, tepotinib, will now be available to treat advanced non-small cell lung cancer patients in Japan with MET exon 15 skipping alterations.

The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.

Increasing understanding of complex tumor biology is reshaping clinical trials in the age of precision medicine, though some view these changes with concern.

In the trial that led to Ayvakit's approval, 84 percent of patients with PDGFRA exon 18 mutations saw their tumors shrink.

The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.

The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.

Enhertu received accelerated approval based on data from a Phase II trial that reported a 60 percent overall response rate.

The approval is based on a Phase III trial showing that Tecentriq significantly improved survival in patients with metastatic non-small cell lung cancer.

The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.

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