Europe - Oncology CHMP Meeting Highlights 18-21 March 2024

Summary:

During its 18-21 March 2024 meeting, the CHMP has granted positive Opinions for the following extensions of indications in Oncology:

Retsevmo (selpercatinib) - Eli Lilly

"Retsevmo as monotherapy is indicated for the treatment of adults with:

• advanced RET fusion positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor
• advanced RET fusion positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)"

Xtandi (enzalutamide) - Astellas

"Xtandi is indicated:

• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1).
• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1).
• for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).
• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).
• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy."

The CHMP has also ackowledged the withdrawal of the following extensions of indication:

Adcetris (brentuximab vedotin) - Takeda:

• Extension of indication to include the use of Adcetris in adults with previously untreated CD30-positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).

The company withdrew the application on 23 February 2024.

Reference link: CHMP Meeting Highlights - 18-21 March 2024; Adcetris Summary of Opinion; Retsevmo Summary of Opinion; Xtandi Summary of Opinion