The US FDA Approves New Indication for Lilly’s Erbitux (cetuximab) + Braftovi (encorafenib) to Treat Metastatic Colorectal Cancer with a BRAF V600E Mutation

September 29, 2021 Auto Bot approval, FDA, Lilly, regulatory 0

Shots:

  • The approval is based on P-III BEACON CRC trial evaluating Braftovi (300mg, qd) + Erbitux vs irinotecan + Erbitux or Folfiri + Erbitux in a ratio (1:1:1) in 441 patients with previously treated mCRC with a BRAF V600E mutation after prior therapy
  • Erbitux + Braftovi showed an improved OS; m-OS (8.4 vs 5.4mos.); ORR (20% vs 2%); CR (5% vs 2%); PR (15% vs 2%) and m-PFS (4.2 vs 1.5mos.)
  • Erbitux is the 1st anti-EGFR antibody approved in combination with encorafenib for adults with previously treated mCRC with a BRAF V600E mutation. On April 8, 2020, the FDA has approved Pfizer’s encorafenib for the same indication

Click here to­ read full press release/ article | Ref: PR Newswire | Image: Forbes

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