Bristol-Myers Squibb Co.'s announcement that it will not seek accelerated approval of its Yervoy/Opdivo combination in first-line lung cancer has disappointed investors and seems to concede a significant edge to competitor Merck & Co. Inc., but it may make more sense from the regulatory perspective, giving the company a better chance for a successful filing.
Bristol, AstraZeneca Changes To IO Strategy Could Ultimately Be Regulatory Gain
Bristol's filing of Yervoy/Opdivo in first-line lung cancer is delayed as the company drops its plans for accelerated approval, but could be on a more solid regulatory footing if the pivotal trial is successful. Meanwhile, AstraZeneca is using adaptive trial design to update MYSTIC, which could result in broader approvals.