FDA Clears AbbVie/AZ All-Oral CLL Regimen with 77% Three-Year PFS, 35% Risk Cut
The FDA approved AbbVie’s all-oral Venclexta plus AstraZeneca’s Calquence regimen for CLL after Phase 3 AMPLIFY data showed 77% three-year PFS versus 67% chemo, cutting progression/death risk by 35%. AbbVie, a 6.57% holding in the iShares US Healthcare ETF, has gained 11.7% and carries a $238.47 average analyst price target.
1. FDA Approval Details
The FDA approved the combination of Venclexta and Calquence as the first all-oral fixed-duration therapy for chronic lymphocytic leukemia. The decision follows AMPLIFY Phase 3 results showing 77% progression-free survival at three years compared to 67% for chemoimmunotherapy, and a 35% reduction in progression or death risk.
2. Implications for AbbVie Stock
AbbVie shares have responded with a modest gain and are trading near recent highs, reflecting investor optimism around the approval. Technical indicators show neutral RSI and bullish MACD trends, and analysts maintain a $238.47 average price target following recent upgrades and downgrades.
3. Impact on iShares US Healthcare ETF
With AbbVie representing 6.57% of the iShares US Healthcare ETF, the approval could boost the ETF’s performance if positive stock momentum continues. The ETF’s sector ranking and recent underperformance suggest broader healthcare trends will influence its overall trajectory alongside this news.