Afinitor

Afinitor Indications/Uses

everolimus

Manufacturer:

Novartis

Distributor:

DKSH
Full Prescribing Info
Indications/Uses
AFINITOR tablets are indicated for the: treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole.
Treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors.
Treatment of adult patients with progressive, well-differentiated (Grade 1 or Grade 2), non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors.
Treatment of adult and pediatric patients, 1 years of age and older, with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of AFINITOR is based on an analysis of change in SEGA volume (see Pharmacology: Pharmacodynamics: CLINICAL STUDIES under Actions). Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.
Treatment of adult patients with renal angiomyolipoma (AML) and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of AFINITOR in the treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. Further follow-up of patients is required to determine long-term outcomes.
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