The Food and Drug Administration found problems during a recent inspection of a Bristol Myers Squibb (BMY) facility in Bothell, Wash., but a Wall Street analyst believes the findings were not serious enough to complicate approval of a cancer drug the company acquired in its $74 billion buyout of Celgene.
In an October report known as a 483, the regulator found “relatively mild” issues with the manufacturing plant, according to Ira Loss of Washington Analysis, who tracks pharmaceutical regulatory and legislative matters for investors. The Bothell plant is one of two facilities that are expected to produce a CAR-T therapy for treating large B-cell lymphoma.
This facility, however, has been largely overshadowed because of events at the other manufacturing plant, which is located in Texas and owned by Lonza, a widely used contract manufacturer. The FDA recently postponed the anticipated Nov. 16 approval date for the medication, which is known as liso-cel, after the agency encountered inspection delays caused by Covid-19.