BRANCE (palbociclib) - Breast cancer

The Committee deems that the clinical benefit of IBRANCE (palbociclib) 75 mg, 100 mg and 125 mg hard capsules and tablets is substantial only:

• in combination with letrozole in women having received no prior therapy for the advanced stage of the disease and not previously treated with a nonsteroidal aromatase inhibitor (letrozole or anastrazole) in the context of adjuvant therapy in the prior 12 months;
• in combination with fulvestrant in women who have received prior endocrine therapy (at the advanced stage or during adjuvant treatment for early progressions).

In combination with letrozole

Considering:

• demonstration of the superiority of pablociclib in combination with letrozole compared to
  letrozole alone in terms of progression-free survival, with a difference in medians of 10.3 months in a randomised, double-blind phase 3 study (PALOMA 2);
• but the lack of evidence of an increase in overall survival (the Committee highlights that the proprietary medicinal product KISQALI (ribociclib) has demonstrated a benefit in terms of overall survival in this context);
• the absence of a relevant clinical benefit in terms of quality of life assessed in exploratory analyses;
• and the safety profile marked by a high risk of haematotoxicity;

the Committee deems that IBRANCE (palbociclib) 75 mg, 100 mg and 125 mg hard capsules and tablets, in combination with letrozole, provides no clinical added value (CAV V) compared to letrozole alone as first-line therapy during the metastatic stage of HR-positive/HER2-negative breast cancer in postmenopausal women, not previously treated with a nonsteroidal aromatase inhibitor (letrozole or anastrazole) in the context of adjuvant therapy in the prior 12 months, in the absence of short-term life-threatening symptomatic visceral involvement.

In combination with fulvestrant

Considering:

• demonstration of the superiority of pablociclib in combination with fulvestrant compared to
  fulvestrant alone in terms of progression-free survival, with a difference of 5.4 months in a randomised, double-blind phase 3 study (PALOMA 3);
• but the lack of evidence of an increase in overall survival;
• the absence of a relevant clinical benefit in terms of quality of life in exploratory analyses;
• and the safety profile marked by a high risk of haematotoxicity;

the Committee deems that IBRANCE (palbociclib) 75 mg, 100 mg and 125 mg hard capsules and tablets, in combination with fulvestrant, provides no clinical added value (CAV V) compared to fulvestrant alone as first-line therapy  in the event of early progression (less than 12 months after the end of adjuvant therapy) or as a second and later-line treatment in postmenopausal women with HR-positive, HER2-negative breast cancer, who have received prior endocrine therapy and in the absence of short-term life-threatening symptomatic visceral involvement.