FDA approves drug based on genetics, not cancer type

Yesterday the FDA approved pembroluzumab for advanced solid tumors with certain types of mutations, regardless of the type of tumor. Keytruda, which is the brand name of pembroluzumab, has already been FDA approved for several advanced cancers. It is in clinical trials for metastatic breast cancer, mostly mTNBC. Keytruda is a targeted immunotherapy.

This is a new way to approach how cancer drugs are used and approved. The approval is excellent since time is very critical for us: If an MBC patient has certain types of mutations the drug would be available to them without having to go through a clinical trial.

forbes.com/sites/elainescha...

2 Replies

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  • Great news Joan!! Thank you!

  • Looks hopeful and very helpful to so many.

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