NEW BRUNSWICK, N.J. — Johnson & Johnson said Monday that it will release new batches of cancer drug Doxil, which has been in short supply this year because of problems at a contract manufacturer.
The new supply might be enough to treat an estimated 1,000 patients, said J&J spokeswoman Lisa Vaga, though the company will have a better count once the allocation process begins. More than 2,000 patients have been on a waiting list to receive the drug, which treats ovarian and other cancers.
J&J said the new supply of Doxil had been manufactured by its contractor, Ben Venue Laboratories, and was awaiting final quality testing when Ben Venue suspended production at its Bedford, Ohio, plant in November to address manufacturing deficiencies. Ben Venue is a unit of Boehringer Ingelheim GmbH.
Regulators from the U.S. and Europe have identified contamination risks and other deficiencies at the Ben Venue plant. European regulators have advised doctors to monitor Doxil patients for adverse events that might be related to contamination.
“We are aware of some recent information about the quality shortcomings at this contracted supplier of Doxil,” Rob Bazemore, president of J&J’s Janssen Products unit, wrote in a letter posted Monday on the Doxil product website. “We have performed thorough quality reviews of this additional supply of Doxil, which included a review of production procedures and extensive sample testing.”
Based on its quality assessment, J&J decided to release the additional Doxil supply, Baze more said.
