NIH/Industry Oncology Partnership Aims For Immunotherapy Biomarkers
The US National Institutes of Health will team up with 11 different drug-makers to explore new biomarkers with a vision of precision oncology medicine.
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Biomarker-Led Claim Is Small Step For Merck's Keytruda, Giant Leap For Cancer Indications
Accelerated approval for patients with microsatellite instability-high or mismatch repair deficient solid tumors is the first time the US FDA has granted an indication that does not specify the location of the tumor – a change precision medicine researchers have been eager to make.
Clinical Trial Challenges: FDA Wants More Prospective Studies, Validated Biomarkers
NIH Director Collins and FDA Commissioner Califf discuss difficulties with ‘big science,’ ‘small crappy trials,’ and ‘data landlords.’
Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.