2021 First-in-Class Large Molecule Drug Approvals (Pt. III)

This deep dive into 2021’s first-in-class large molecule drug approvals is the third in a series of focus articles on 2021’s novel large molecule drugs. See part one here, and part two here.

For each of the 11 first-in-class large molecule drug approvals of 2021 (excluding vaccines), we’ll explore in more detail:

  • how they work (MoA)
  • key approval endpoints and disease context
  • how they’re different from previous treatments
  • how they were discovered
  • and more scientific highlights.

One example covered in more detail in the 11 slides is Rybrevant (amivantamab-vmjw), an injectable bispecific epidermal growth factor receptor (EGFR)- directed and mesenchymal-epithelial transition (MET) receptor- directed antibody that is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, where disease has progressed on or after platinum-based chemotherapy. Among such patients, amivantamab significantly improved overall response rate (ORR, 40%) as well as duration of the response (DOR, over 11 months). The results were so favorable that this drug moved directly from a Ph. I trial into a Biologics License Application. 

For site-wide searchability, all summaries appear below to Premium members, but it’s much easier to flip through your Premium slide deck 😉. You can find the poster in part one and the small molecules series here).

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