Alpelisib

• Tablets 50mg, 150mg, 200mg

Notes

1. NICE TA816: Alpelisib (Piqray) plus fulvestrant is recommended as an option for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated, locally advanced or metastatic breast cancer in adults (August 2022), only if:
   1. their cancer has progressed after a CDK4/6 inhibitor plus an aromatase inhibitor and
   2. the company provides alpelisib according to the commercial arrangement.

Idelalisib

• Tablets 100mg, 150mg

Notes

1. NICE TA359: Idelalisib for treating chronic lymphocytic leukaemia (October 2015):
   1. Idelalisib (Zydelig), in combination with rituximab, is recommended
      • for untreated chronic lymphocytic leukaemia in adults with a 17p deletion or TP53 mutation or
      • for chronic lymphocytic leukaemia in adults when the disease has been treated but has relapsed within 24 months.
   2. Idelalisib is recommended only if the company provides the drug with the discount agreed in the simple discount agreement.
2. NICE TA604: Idelalisib (Zydelig) is not recommended, within its marketing authorisation, for treating follicular lymphoma that has not responded to 2 prior lines of treatment in adults (October 2019).
3. MHRA Drug Safety Update (May 2016): Idelalisib (Zydelig): interim measures following signal of serious infection and deaths related to infection found in clinical trials.
4. MHRA Drug Safety Update (September 2016): Idelalisib (Zydelig): updated indications and advice on minimising the risk of infection.