USFDA delays decision on Bristol Myers cancer therapy due to COVID-19 travel curbs
New Delhi: Bristol Myers Squibb said on Monday the U.S. health regulator has deferred a decision on an experimental blood cancer therapy that it acquired in the $74 billion buyout of Celgene due to coronavirus-related travel restrictions.
The U.S. Food and Drug Administration (FDA) was unable to inspect a third-party manufacturing facility in Texas, a step required before the approval of the drug liso-cel, the company said.
The health regulator warned earlier this year its level of timely reviews and approvals of marketing applications could be impacted by the COVID-19 crisis, which forced the FDA in October to also delay a decision on a Spectrum Pharmaceuticals drug.
Bristol Myers said on Monday the agency had deferred its application until the inspection can be completed. The FDA was earlier expected to complete the review process by Nov. 16.
The agency's approval of liso-cel by Dec. 31, 2020, is one of the remaining milestones required for Celgene investors to receive a conditional payment of $9 per share.