REGULATORY · MARKET STRUCTURE · COMPETITIVE · USA
FDA approves fixed-duration oral combo for first-line CLL/SLL
Yahoo
23 Feb · 7:15 AM
Change
The US FDA approved AstraZeneca’s Calquence (acalabrutinib) plus venetoclax as a first-line treatment for adults with CLL and SLL as the first all-oral, fixed-duration regimen.
Why it matters
The label adds a fixed-duration, all-oral Calquence+venetoclax option in the first-line CLL/SLL setting, shifting the set of on-label alternatives away from open-ended therapy and IV-based regimens for eligible patients. Trial results cited with the approval include a 77% progression-free rate at three years versus 67% for standard chemotherapy, with a reported 35% reduction in risk of progression or death, which can affect comparative value assessments. The decision changes contracting and formulary evaluation inputs because two branded oral agents are used together under an FDA-approved regimen. It also alters competitive positioning versus chemoimmunotherapy and other targeted first-line approaches by introducing a time-bounded labeled course.
Implications
- • New labeled first-line CLL/SLL option: all-oral, fixed-duration combo
- • Formulary and contracting decisions now include dual-oral branded regimen costs
- • Competitive pressure increases on chemoimmunotherapy and other first-line regimens
- • Clinical pathway updates required to reflect new FDA-approved regimen
Who is affected
- • Hematologists/oncologists treating first-line CLL/SLL
- • US pharmacy benefit managers and health plan formulary committees
- • Hospital/health-system oncology pharmacy and therapeutics (P&T) committees
- • AstraZeneca and AbbVie commercial teams for Calquence and venetoclax
Source
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Topics
Law & Public Safety Regulatory Actions Health & Medicine Medicine Pharma & Biotech