Europe: Oncology: CHMP Highlights June 2022 - Competitor Update

Summary: On 24 June 2022, CHMP released its meeting highlights for the month of June. Key discussion points are as follows:

Marketing Authorisation Applications:

• Pepaxti (melphalan flufenamide) (Orphan) - Oncopeptides AB
  • Indication: Treatment of multiple myeloma
  • Positive CHMP opinion
• Scemblix (asciminib) (Orphan) – Novartis
  • Indication: Treatment of Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+CML-CP)
  • Positive CHMP opinion
• Vegzelma (bevacizumab)(Biosimilar) - Celltrion Healthcare Hungary Kft
  • Indication: Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix
  • Positive CHMP opinion

Re-examination of recommendations for new medicines

• Hervelous (trastuzumab) - Prestige Biopharma Belgium
  • Indication: Treatment of certain forms of breast cancer and gastric (stomach) cancer
  • Positive CHMP opinion
• Tuznue (trastuzumab) - Prestige Biopharma Belgium
  • Indication: Treatment of certain forms of breast cancer and gastric (stomach) cancer
  • Positive CHMP opinion

Extensions of Indications:

• Enhertu (trastuzumab deruxtecan) - Daiichi Sankyo Europe GmbH
  • Change to existing indication: Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two one or more prior anti HER2 based regimens.
  • Positive CHMP Opinion
• Imbruvica (ibrutinib) - Janssen-Cilag
  • Change to existing indication: to include its use in combination with venetoclax.
  • Positive CHMP Opinion
• Lynparza (Olaparib) – Astrazeneca
  • New indication: adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
  • Positive CHMP Opinion

Notification link: Pepaxti,  Scemblix, Vegzelma, Hervelous, Tuznue, Enhertu, Imbruvica, Lynparza, Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022

Fonte: Newsletter GRIP