Europe - Oncology CHMP Meeting Highlights April 22 -25, 2024

During its April 22-25, 2024 meeting, the CHMP has granted positive Opinions for the following extensions of indications in Oncology:

• The committee adopted a positive opinion for Fruzaqla (fruquintinib, Takeda), indicated for the treatment of patients with previously treated metastatic colorectal cancer.
• The CHMP gave a positive opinion for Truqap (capivasertib, AZ), for the treatment of locally advanced or metastatic breast cancer with one or more specific mutations.
• Positive recommendation on new generic medicine, Eribulin (Baxter)
• Extension of Indication
• Alecensa, Roche: Adjuvant treatment of resected non‑small cell lung cancer (NSCLC)
• Opdivo, BMS: in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
• Rozlytrek, Roche: Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients  older than 1 month with solid tumours  that have a NTRK gene fusion
• Rybrevant, Janssen: in combination with carboplatin and pemetrexed for the first‑line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutations.