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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  • Johnson & Johnson
  • Roche
  • Pfizer
  • Novartis
  • Bayer
  • Merck
  • Sanofi
  • GlaxoSmithKline
  • AbbVie
  • Eli Lilly
  • Boehringer Ingelheim
  • Amgen
  • Bristol-Myers Squibb
  • Gilead
  • AstraZeneca
  • Teva
  • Novo Nordisk
  • Merck KGaA
  • Takeda
  • Celgene (BMS)
  • Biogen
  • Astellas
  • Daiichi Sankyo
  • Regeneron
  • UCB
  • Eisai
  • Servier
  • Kyowa Kirin
  • Shionogi
  • Vertex
  • Lundbeck
  • Taisho
  • Ono
  • Seagen
  • Incyte
  • LEO Pharma
  • Janssen
  • Galapagos
  • Idorsia
  • Astex
  • Arvinas
  • Kymera
  • Relay
  • Schrodinger
  • Mirati
  • Revolution
  • Nimbus
  • Plexxikon
  • Forma
  • Arcus
  • RA Capital
  • ARCH Venture Partners
  • MPM Capital
  • Orbimed
  • The Column Group
  • 5AM Ventures
  • Versant Ventures
  • Deerfield
  • Goldman Sachs
  • Citi
  • Piper Sandler
  • Softbank
  • …and hundreds of others