Next-generation sequencing is emerging as the rate-limiting factor for how fast and broadly tissue-agnostic drug development will take off in drug development. By engaging community oncologists, some companies hope to spread the word and enable more patients access to trials earlier in their disease.
This month saw the third agent approved based on its molecular target rather than the cancer’s tissue of origin, when Japan’s Ministry of Health, Labor & Welfare granted approval to Roche’s Rozlytrek entrecitinib to treat NTRK-positive cancer.
Rozlytrek joins Bayer AG’s Vitrakvi larotrectinib, also approved for NTRK-positive cancers, and Merck & Co.’s Keytruda pembrolizumab, which was approved in May 2017 to treat MSI-H or mismatch repair deficient tumors.
“This has become a more viable approach to drug development now that we have this regulatory precedence,” said Kate Haviland, COO at Blueprint Medicines Inc.
But better efficiency in finding the right mutations to target, and the patients who carry them, is critical for wider adoption. There is still a patchwork integration of NGS in practice. How companies access and deploy the technology will shape the way tissue-agnostic drug development takes hold in cancer care.
“It’s one thing to test 100 patients to identify one who might benefit, but if you can test