MHRA Drug Safety Update (June 2021): CDK4/6 inhibitors (abemaciclib, palbociclib, ribociclib): reports of interstitial lung disease and pneumonitis, including severe cases. Ensure that patients taking these medicines are aware of the need to seek advice right away if they develop new or worsening respiratory symptoms.

Abemaciclib

• Tablets 50mg, 100mg, 150mg

Notes

1. NICE TA563: Abemaciclib (Verzenios), with an aromatase inhibitor is recommended, within its marketing authorisation, as an option for treating locally advanced or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based therapy in adults. Abemaciclib is recommended only if the company provides it according to the commercial arrangement. (February 2019).
2. NICE TA725: Abemaciclib (Verzenios) plus fulvestrant is recommended as an option for treating hormone receptor‑positive, human epidermal growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic breast cancer in adults who have had endocrine therapy (September 2021) only if:
   1. exemestane plus everolimus is the most appropriate alternative to a cyclin‑dependent kinase 4 and 6 (CDK 4/6) inhibitor and
   2. the company provides abemaciclib according to the commercial arrangement.
3. NICE TA810: Abemaciclib (Verzenios) with endocrine therapy is recommended, within its marketing authorisation, as an option for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer in adults whose disease is at high risk of recurrence (July 2022), defined by the following clinical and pathological features:
   1. at least 4 positive axillary lymph nodes, or
   2. 1 to 3 positive axillary lymph nodes, and at least one of the following criteria:
      • grade 3 disease (defined as at least 8 points on the modified Bloom-Richardson grading system or equivalent), or
      • primary tumour size of at least 5cm
   3. the company provides it according to the commercial arrangement.
4. Refer to MHRA Drug Safety Update above.
   

Palbociclib

• Capsules 75mg, 100mg, 125mg

Notes

1. NICE TA495: Palbociclib (Ibrance), with an aromatase inhibitor, is recommended within its marketing authorisation, as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy in adults. Palbociclib is recommended only if the company provides it with the discount agreed in the patient access scheme. (December 2017).
2. NICE TA619: Palbociclib (Ibrance) with fulvestrant is recommended for use within the Cancer Drugs Fund as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in people who have had previous endocrine therapy only when the criteria of the NICE TA are met (January 2020).
3. NICE TA836: Palbociclib (Ibrance) plus fulvestrant is recommended as an option for treating hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer in adults who have had endocrine therapy (October 2022), only if:
   1. exemestane plus everolimus is the most appropriate alternative to a cyclin-dependant kinase 4 and 6 (CDK4/6) inhibitor and
   2. the company provides it according to the commercial arrangement.
4. Refer to MHRA Drug Safety Update above.

Ribociclib succinate

• Tablets 200mg

Notes

1. NICE TA496: Ribociclib (Kisqali), with an aromatase inhibitor, is recommended within its marketing authorisation, as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy in adults. Ribociclib is recommended only if the company provides it with the discount agreed in the patient access scheme. (December 2017).
2. NICE TA687: Ribociclib (Kisqali) plus fulvestrant is recommended as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy (March 2021) only if:
   1. exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor, and
   2. the company provides ribociclib according to the commercial arrangement.
3. Refer to MHRA Drug Safety Update above.