Another cancer drug is disappearing from the market soon, and while there are alternatives, the production challenges faced by its maker illustrate why so many cancer treatments have fallen into short supply.
Danish drugmaker Lundbeck has told doctors in a letter that beginning in December, it will stop supplying its leukemia drug Elspar because it has been unable to get a steady supply of the API.
In an email to FiercePharma, Matt Flesch, Lundbeck senior manager of communications, explained the drug is a very old biological product and difficult to manufacture. The company has used a contractor to make Elspar. Flesch said that when Lundbeck acquired the product in 2006, the company had to update underlying process technology and analytical methods to meet new guidelines for biologics. Still, he said, "Authorities in some markets outside the U.S. have been reluctant to accept many of these improvements, due to evolving and often tighter controls linked to biologics." Even with all of the investments, the company has had difficulty getting a guaranteed supply of the API, and to do that would require additional process and specification changes that might not be approved by regulators.
Most of the drug shortages in the last year are tied to some kind of production issue, often because the FDA has found plant problems and companies have had to halt production to make upgrades. The industry finds itself in a bit of a catch-22 with the manufacture of many of the old-line cancer treatments. They are often sterile drugs that require special care to make, but because they have thin profit margins, companies find it difficult to justify investing in plant upgrades. Yet, if they decide they are not worth the return on investment, there is not always an alternative for patients who rely on them.
That is not the case with Elspar, Lundbeck emphasized. "As noted in the letter, our decision to discontinue Elspar was based on two main factors. First and most importantly, other forms of asparaginase are currently available, which means that patients in need of this therapy will continue to have alternatives. Secondly, there are numerous challenges associated with securing a reliable global and long-term product supply chain."
- see the Lundbeck letter (PDF)
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