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FDA to Speed Up Review of Krazati Combo for Metastatic CRC

The Food and Drug Administration granted a priority review to Krazati plus Erbitux for KRAS G12C-mutant locally advanced or metastatic colorectal cancer.

Anne kerberKrazati erbituxBristol myers squibbDrug administrationNational comprehensive cancer networkCell therapyNew england journalPancreatic cancerClinical oncologyColorectal cancerPriority review

Adagrasib Plus Cetuximab Under Review for KRASG12C-Mutated Advanced Colorectal CA

The application is supported by data from the multicohort phase 2 KRYSTAL-1 study, which evaluated adagrasib in heavily pretreated patients with KRASG12C-mutated advanced CRC.

Anne kerberBristol myers squibbDrug administrationPriority reviewNew drug applicationPrescription drug user fee actCell therapyBristol myers

Bristol-Myers Squibb (BMY) Announces FDA Acceptance of sBLA for KRAZATI in Combination with Cetuximab

Bristol-Myers Squibb (BMY) Announces FDA Acceptance of sBLA for KRAZATI in Combination with Cetuximab
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Anne kerberBristol myers squibbDrug administrationPrescription drug user fee actCell therapyBristol myers

U S Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI® (adagrasib) in Combination with Cetuximab as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or

U.S. FDA has assigned a target action date of June 21, 2024 Application based on results from the Phase 1/2 KRYSTAL-1 study .

Bristol myers squibbAnne kerberDrug administrationExchange commissionEuropean commissionAccepts supplemental new drug applicationTargeted treatment optionPreviously treatedMutated locally advancedMetastatic colorectal cancerMyers squibbPrescription drug user fee actCell therapyBristol myersPrescribing informationBetter future

FDA Grants Priority Review to Adagrasib/Cetuximab Combination Therapy in KRAS G12C–Mutant CRC

A sNDA for adagrasib plus cetuximab in advanced KRAS G12C–mutated colorectal cancer was granted priority review by the FDA.

Bristol myers squibbAnne kerberBristol meyers squibbDrug administrationPrescription drug user fee actCell therapyColorectal cancerMss crcFast track designationKras g12c

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