Recent weeks have been dominated by clinical and regulatory developments in two settings: second-line cervical cancer and perioperative treatment of non-small cell lung cancer. The former saw Merck & Co’s Keytruda convert its accelerated US approval into a full green light, leading Agenus to pull its submission for balstilimab less than two months before its Pdufa date.
In neoadjuvant NSCLC, meanwhile, Bristol Myers Squibb celebrated the Opdivo/chemo combo Checkmate-816 study, which on November 8 added an event-free survival hit versus chemo alone to the positive pathological complete response rate readout toplined a year ago. This could position Opdivo to become the first checkpoint-blocking MAb to be approved for neoadjuvant NSCLC – quite the turnaround for Bristol.
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