News Related to Afinitor

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FDA Approves First-Line Acalabrutinib Regimen for CLL/SLL, Expands NSCLC Dosing Options

Feb 21, 2026

The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.

FDA Accepts Roche NDA for Giredestrant in ER+/HER2- Breast Cancer with ESR1 Mutations

Feb 20, 2026

The FDA has accepted Roche's new drug application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated breast cancer, with a decision expected by December 18, 2026.