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.
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.
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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.
Loxo, Bayer biomarker-driven drug maintains high response rates in ESMO presentation
Larotrectinib showed an 81 percent response rate among 109 patients with NTRK fusion-positive cancers, with most continuing to respond or receiving surgery with curative intent after more than a year.