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The Lomustine Project

The API Innovation Center’s initial project is to seek a source of U.S. produced-API for lomustine, a chemotherapy drug used to treat glioblastoma. Glioblastoma is the most common and deadliest type of brain cancer. According to the National Brain Tumor Society, more than 13,400 Americans will be diagnosed with glioblastoma this year. The five-year survival rate for glioblastoma patients is only 6.8%. Currently, there is no U.S. source of lomustine. 

Our Project

Resolving the Lomustine Crisis for Glioblastoma Patients

According to the Society for Neuro-Oncology, “the field of neuro-oncology is in the midst of a crisis with lomustine.” Recently, the sole foreign-sourced manufacturer of lomustine significantly increased the price of the drug, making clinical trials cost-prohibitive. In 2021, the manufacturer pulled out of the federal discount program for Medicare patients, leaving many patients struggling to pay for treatment. The APIIC is working in partnership with Continuity Pharma and the Glioblastoma Foundation to resolve the lomustine crisis utilizing the advanced technologies of continuous flow manufacturing.  

What we do

What is Continuous Flow Manufacturing?

Continuous flow is one type of advanced manufacturing. Continuous flow manufacturing is a fully integrated drug manufacturing process that utilizes sequential flow unit operations to produce pharmaceutical API and drugs.
 
The benefits of advanced manufacturing include:
    • Reduces manufacturing and labor costs while enhancing workplace safety
    • Improves manufacturing agility with improved quality controls to minimize waste
    • Accelerates time to market
    • Eliminates supply disruptions with on-demand production
    • Smaller environmental footprint
    • New workforce development opportunities 
In addition to continuous flow, the APIIC will evaluate the right technology matched with the right essential and critical drug molecule to strengthen the manufacturing competitiveness of the U.S.

What we’ve done

The APIIC has brought together over 10 partners for the U.S. production of lomustine to:

  • Create a sustainable supply for patient treatment
  • Reduce the cost of the drug
  • Enable new drug clinical trials

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Contact the Center

For more information about the Center and its work to de-risk the return of API production back to the U.S., contact us today. 

Contact us