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Melflufen expanded access program open in the U.S.

by TerryH on Thu Oct 01, 2020 10:14 am

It was announced this morning that an expanded access program has been opened for melflufen in the U.S. This means that, if you're eligible, you can arrange to be treated with the drug even though it's still being reviewed for potential approval by the Food and Drug Administration.

To take part in the program, you have to be an adult myeloma patient whose received at least two previous lines of treatment and you must be refractory (resistant) to treatment with at least one immunomodulatory drug (e.g., thalidomide, Revlimid, or Pomalyst), at least one proteasome inhibitor (e.g., Velcade, Ninlaro, or Kyprolis), and at least one CD38 monoclonal antibody (e.g., Darzalex or Sarclisa).

More details about the program can be found in the related press release and the program's information page at clinicaltrials.gov:

"Oncopeptides Initiates U.S. Expanded Access Program With Melflufen In Triple-Class Refractory Multiple Myeloma," Oncopeptides press release, Oct. 1, 2020.

"Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma (sEAPort)," information page at clinicaltrials.gov .

TerryH

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