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VERZENIOS (abemaciclib) - Breast cancer
Reason for request
Summary of opinion
Favourable opinion for maintenance of reimbursement only in the treatment of HR-positive/HER2-negative locally advanced or metastatic breast cancer in postmenopausal women without short-term life-threatening symptomatic visceral involvement:
- in combination with fulvestrant, as first-line treatment of metastatic disease in women in early relapse following adjuvant endocrine therapy, or as second-line treatment of metastatic disease following a first line of endocrine therapy;
- in combination with an NSAI (letrozole or anastrozole) as first-line treatment ofmetastatic disease, either in women with cancer diagnosed at an advanced stage, or in women with late relapse following adjuvant endocrine therapy.
Clinical Benefit
| Substantial |
The clinical benefit of VERZENIOS 50, 100 and 150 mg (abemaciclib) film-coated tablets remains substantial:
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Clinical Added Value
| moderate |
VERZENIOS (abemaciclib) in combination with fulvestrant provides a moderate clinical added value (CAV III) compared to fulvestrant alone in the treatment of postmenopausal women with HR-positive / HER2-negative locally advanced or metastatic breast cancer, without short-term life-threatening symptomatic visceral involvement, as first-line treatment of metastatic disease in women in early relapse following adjuvant endocrine therapy, or as second-line treatment of metastatic disease following a first line of endocrine therapy. VERZENIOS (abemaciclib) in combination with letrozole or anastrozole provides a minor clinical added value (CAV IV) compared to letrozole or anastrozole alone in the treatment of postmenopausal women with HR-positive / HER2-negative locally advanced or metastatic breast cancer, without short-term life-threatening symptomatic visceral involvement, as first-line treatment of metastatic disease, either in women with cancer diagnosed at an advanced stage, or in women with late relapse following adjuvant endocrine therapy. |
