Some cancer patients now have to find other options as Bristol Myers' Abraxane falls into shortage from manufacturing woes
When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.
“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.
Since February, Hogan has been infused with a combo of Abraxane and Gemzar, she said, which “has been a miracle for me,” noting two successive scans with no cancer progression. “There has been no discussion of an alternative. I think they are waiting to see if it resolves itself. But I was told that something needs to happen — that they don’t want to go beyond a month without it,” she added.
Several other cancer patients reached out to Endpoints asking about why they haven’t been able to get their Abraxane infusions. The FDA’s website lists manufacturing delays but says little on when more is coming. Two cancer doctors also confirmed that Abraxane is replaceable with the generic form of paclitaxel, although one noted that Abraxane’s formulation is better tolerated, but it’s “not a life or death difference.”
Bristol Myers said it would provide a fuller update in mid-November, and confirmed that it’s prioritizing allocations of the drug globally to minimize disruptions.
Abraxane brought in $1.2 billion in sales for BMS in 2020, and $610 million in the first six months of 2021.
“A BMS facility that manufactures Abraxane must complete additional testing before manufacture and release of additional supply, to ensure product quality and safety. We have prioritized resources to monitor and remedy this situation,” a BMS spokesperson said in an emailed statement. “There is no impact to the quality of Abraxane currently on the market.”
But those manufacturing issues have been lingering for more than a year and a half after Chinese officials ordered BeiGene to stop selling Abraxane in the wake of an alarming inspection, though the manufacturing issues at the root of China’s import suspension remain unresolved. BeiGene disclosed in an SEC filing earlier this month that BMS-Celgene is trying to end its agreement with the company as it cannot manufacture the drug in China or the US.
While BeiGene looks to mend its relationship with BMS, China’s drug regulators at the National Medical Products Administration no longer allow certain manufacturing of Abraxane from a site in Melrose Park, IL, which was hit with an FDA warning letter more than a decade ago. Another manufacturing facility in Phoenix became the primary facility for Abraxane, according to BeiGene’s filing. BMS’ Celgene initially acquired those sites as part of its $2.9 billion buyout of Abraxis.
“In July 2021, media fill testing at that [Phoenix] facility revealed a failure. Following a root cause investigation, corrective and preventative actions were implemented, but testing resulted in the rejection of additional vials. Celgene is continuing to correct the underlying issue, but all manufacturing production activities with respect to Abraxane have ceased at the Phoenix facility for the time being and the U.S. Food and Drug Administration has been notified,” according to a notice from BMS to BeiGene.
The announcement of the shortage comes on the heels of the FDA denying a petition by Bristol Myers to stall generic versions of Abraxane. BMS settled with Teva’s Actavis, allowing at least one Abraxane generic to enter the market on March 31, 2022.