TRENTON, N.J. (AP) — Johnson & Johnson is making more headway in restoring supplies of a crucial cancer drug unavailable to many patients since the contract manufacturer producing it, Ben Venue Laboratories, shut down a year ago due to serious contamination and other quality problems at its Ohio factory.
Access to Doxil, or Caelyx as it's called in the European Union and some other places, had been limited to existing patients since last fall amid dwindling supply. The drug treats advanced breast and ovarian cancers, the bone marrow cancer multiple myeloma and Kaposi's sarcoma, a blood vessel cancer. For many patients, it was the only effective option.
A J&J spokeswoman said Wednesday that new stock of Caelyx is now available to at least some new patients in Europe. That's after the European Medicines Agency approved an arrangement under which Ben Venue will do the initial manufacturing steps and another company will then handle sterile packaging of the injected drug into vials.
Doctors in European Union countries are being notified to use a new Internet-based ordering and reservation system for Caelyx.
"We're now slowly building up stock and we are organizing access via this online portal ... on a first-come, first-served basis," Satu Glawe, a spokeswoman for J&J's Janssen Pharmaceuticals Inc. unit, said Wednesday.
Preference will go to EU patients currently taking the drug, then to new patients without other options and finally to other new patients, she said. The company will resume supply in other countries after getting approvals there.
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