Coronavirus-related travel restrictions is the reason for the delay
Bristol Myers Squibb said that the US 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 US 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 November 16.
Reuters
