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).