Eli Lilly (LLY), Bristol-Myers Squibb (BMY) ERBITUX w/ FOLFIRI Granted Full-Approval by FDA
Tweet
Share
E-mailGet Alerts LLY Hot Sheet
Join SI Premium – FREE
Eli Lilly and Company (NYSE: LLY) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that ERBITUX (cetuximab) in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) has been granted full approval by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with KRAS mutation-negative (commonly known as KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use. ERBITUX is not indicated for the treatment of KRAS mutation-positive colorectal cancer. Concurrently, the FDA also approved the first KRAS companion diagnostic test, the therascreen® KRAS diagnostic kit developed by QIAGEN.
The new indication is based on data from the CRYSTAL (Cetuximab combined with iRinotecan in first-line therapY for metaSTatic colorectAL cancer) trial, a Phase 3 open-label, randomized, multicenter study conducted outside the U.S. that used European Union (EU)-approved cetuximab as the clinical trial material. ERBITUX provides approximately 22 percent higher exposure relative to the EU-approved cetuximab; these pharmacokinetic data, together with the results of this trial and other clinical trial data, establish the efficacy of ERBITUX at the recommended dose in combination with FOLFIRI for first-line KRAS mutation-negative (wild-type) EGFR-expressing mCRC.
With today’s approval, ERBITUX is now the first and only FDA-approved therapy for a specific subset of mCRC patients, targeting those with KRAS mutation-negative (wild-type) tumors. This is based on the positive CRYSTAL study with progression-free survival (PFS) as the primary endpoint in the all randomized patient population treated with EU-approved cetuximab plus FOLFIRI (the CRYSTAL regimen) versus FOLFIRI alone.
The Full Prescribing Information for ERBITUX includes a Boxed WARNING regarding infusion reactions. Serious infusion reactions occurred with the administration of ERBITUX in approximately 3 percent of patients in clinical trials, with fatal outcome reported in less than 1 in 1000. Healthcare providers should immediately interrupt and permanently discontinue ERBITUX infusion for serious infusion reactions.
The new indication is based on data from the CRYSTAL (Cetuximab combined with iRinotecan in first-line therapY for metaSTatic colorectAL cancer) trial, a Phase 3 open-label, randomized, multicenter study conducted outside the U.S. that used European Union (EU)-approved cetuximab as the clinical trial material. ERBITUX provides approximately 22 percent higher exposure relative to the EU-approved cetuximab; these pharmacokinetic data, together with the results of this trial and other clinical trial data, establish the efficacy of ERBITUX at the recommended dose in combination with FOLFIRI for first-line KRAS mutation-negative (wild-type) EGFR-expressing mCRC.
With today’s approval, ERBITUX is now the first and only FDA-approved therapy for a specific subset of mCRC patients, targeting those with KRAS mutation-negative (wild-type) tumors. This is based on the positive CRYSTAL study with progression-free survival (PFS) as the primary endpoint in the all randomized patient population treated with EU-approved cetuximab plus FOLFIRI (the CRYSTAL regimen) versus FOLFIRI alone.
The Full Prescribing Information for ERBITUX includes a Boxed WARNING regarding infusion reactions. Serious infusion reactions occurred with the administration of ERBITUX in approximately 3 percent of patients in clinical trials, with fatal outcome reported in less than 1 in 1000. Healthcare providers should immediately interrupt and permanently discontinue ERBITUX infusion for serious infusion reactions.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- FDA authorizes 11 ZYN Ultra nicotine pouches for Philip Morris
- Gray Media closes $750M note offering to refinance higher-rate debt
- loanDepot receives NYSE non-compliance notice over stock price
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
