Bayer’s tumor-agnostic cancer drug gets European nod
Bayer said Monday that the European Medicines Agency had approved Vitrakvi for NTRK fusion-positive cancers. The drug won U.S. Food and Drug Administration accelerated approval in November.
Roche drug is third to win biomarker-driven cancer approval from FDA
On Thursday, Roche’s Rozlytrek won simultaneous FDA labels for NTRK fusion-positive solid tumors and ROS1-positive non-small cell lung cancer.
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Japanese regulators say ‘engage’ on Roche’s Trk inhibitor
The FDA is expected to reach a decision by August on the drug, Rozlytrek, a tumor-agnostic cancer drug and potential competitor to Bayer's Vitrakvi.
Lilly and Bayer’s LOXO-195 shows efficacy in TRK inhibitor-resistant tumors at AACR
Among 29 patients, the drug - designed for patients who become resistant to TRK inhibitors like Vitrakvi - showed a 34 percent response rate, according to Phase I data.
If FDA says ‘make it so,’ Loxo’s Vitrakvi could see competition from Roche’s entrectinib
The agency set an August PDUFA date for entrectinib, which it gave priority review. It did the same for another Roche drug, polatuzumab vedotin, for high-grade lymphoma.
These are the biggest biopharma stories we covered in 2018
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FDA approval puts Loxo, Bayer’s Vitrakvi on the rails to value-based care
That the drug will only be given to patients shown through testing to harbor a genetic anomaly that increases the odds of a response makes its approval an important milestone in the evolution of value-based care.
Loxo, Bayer’s Vitrakvi wins FDA approval. Now comes the hard part: finding patients
An oncologist compared NTRK fusion patients to a needle in a haystack, but had some clues of how to find them. Still, drugs like Vitrakvi call for genomic sequencing of all cancer patients, he said.