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Pfizer New
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Pfizer’s Braftovi Regimen Receives US FDA Full Approval for Metastatic Colorectal Cancer

Shots: The US FDA has granted full approval to Braftovi + cetuximab & fluorouracil-based CT for the treatment of adults with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation Approval was backed by the P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in pts, randomized to Braftovi + cetuximab (n=158), Braftovi + cetuximab + mFOLFOX6 (n=236),…
5 days ago

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Pfizer New
NEWS

Pfizer Reports P-III (BREAKWATER) Trial Cohort 3 Results on Braftovi (Encorafenib) Regimen for Certain Metastatic Colorectal Cancer (mCRC)

Shots: Pfizer has reported data from Cohort 3 of P-III (BREAKWATER) trial, assessing Braftovi (300mg, PO, QD) + cetuximab & FOLFIRI (n=73) vs FOLFIRI ± Avastin (n=74) in pts with previously untreated BRAF V600E-mutated mCRC In Cohort 3, the combination improved PFS as assessed by BICR, with OS showing meaningful prolonged improvement; ORR results were…
February 18, 2026

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Pfizer New
NEWS

Pfizer Reports P-III (BREAKWATER) Trial Results on Braftovi (Encorafenib) Regimen for Certain Metastatic Colorectal Cancer (mCRC)

Shots: Pfizer has reported data from Cohort 3 of P-III (BREAKWATER) trial, assessing Braftovi (300mg, PO, QD) + cetuximab & FOLFIRI (n=73) vs FOLFIRI ± Avastin (n=74) in pts with previously untreated BRAF V600E-mutated mCRC In Cohort 3, the combination improved ORR (64.4% vs 39.2%), with 57.4% vs 34.5% achieving ≥6mos. responses; mDoR was not…
January 12, 2026

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Takeda
NEWS

Takeda Receives Health Canada’s Approval for Fruzaqla (fruquintinib) to Treat Metastatic Colorectal Cancer (mCRC)

Shots: Health Canada has approved Fruzaqla to treat mCRC patients receiving prior therapy or are ineligible for SoCs based on 2 P-III (FRESCO & FRESCO-2) trials. In addition, the CDA-AMC & INESSS recommended reimbursement of Fruzaqla FRESCO assessed Fruzaqla + BSC vs PBO + BSC in 3L+ mCRC patients, while FRESCO-2 assessed Fruzaqla +…
January 21, 2025

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