Order May Impact Mesothelioma Drug Availability

Mesothelioma patients on certain types of chemotherapy drugs may have easier access to their treatment in the wake of an executive order from President Obama.

The President is calling on the Food and Drug Administration (FDA) to “take action” to combat shortages of certain critical medications. On the list of drugs in dwindling supply is the chemotherapy drug cisplatin, one of the most commonly-used drugs to treat mesothelioma. Mesothelioma is a rare but deadly form of cancer triggered by asbestos exposure that affects an estimated 2,500 Americans each year. Cisplatin, in combination with pemetrexed (Alimta) is the FDA approved first line treatment for malignant pleural mesothelioma.

At a news conference in Washington last week, Health and Human Services Secretary Kathleen Sebelius reported that the number of shortages of prescription drugs like cisplatin tripled from 2005 to 2010. According to the FDA, so far this year the number of drugs in short supply rose to 200 from 178 in 2010.

Cisplatin is used both for both pleural mesothelioma and for peritoneal mesothelioma (off-label). The drug is reportedly in short supply in part because of its popularity, not only for mesothelioma but also for other, more common cancers including testicular, bladder and ovarian. Because the patents for cisplatin have expired and it is now available in a generic form, Bristol-Myers Squibb has stopped making the brand-name version of the drug. Generic drugs are much less profitable for drug companies, prompting some to stop their production, triggering shortages. Among other things, the new executive order requires companies to give more advance notice if they plan to stop producing a drug like cisplatin and calls on the FDA to step up its inspection and approval of new drug manufacturing plants.

The Obama administration calls the executive order a ‘first step’ toward addressing the drug shortages. According to the New York Times, the administration is also considering stockpiling certain crucial cancer medications as insurance against future manufacturing disruptions.

At the same time, the makers of the drug most often paired with cisplatin for treating mesothelioma have gotten a boost from regulators in Europe. Eli Lilly has recently received word that Alimta has been approved as a continuation maintenance therapy for patients with advanced non-squamous cell lung cancer. Although Alimta is not in short supply, it is expensive (estimated $1,700 per vial), a situation the new executive order could address. No word yet on what impact the expansion of Alimta’s market could have on its availability for treating mesothelioma.

Sources:

Harris, Gardiner, “Obama Tries to Speed Response to Shortages in Vital Medicine”, October 31, 2011, The New York Times online. Taylor, Lynne, “Obama: ‘we can’t wait’ on drug shortages, price gouging”, November 1, 2011, Pharma Times online. Grogan, Kevin, “Expanded approval for Lilly’s Alimta in Europe”, October 31, 2011, Pharma Times online.