Repotrectinib

EMA's CHMP recommended 8 new medicines for approval, including Augtyro, Gohibic, and Lazcluze, and 4 biosimilars. Extensions of indication were recommended for 11 existing medicines, while marketing authorisations were refused for Cinainu and Kizfizo. CHMP also recommended Leqembi for Alzheimer's patients with specific genetic profiles and updated safety advice for Mysimba. Applications for Izelvay and Inaqovi were withdrawn.

Zai Lab reports Q3 2024 net product revenue growth of 47% y-o-y to $101.8M, positive China bridging study results for KarXT in schizophrenia, and global Phase 1 data suggesting best-in-class potential for ZL-1310 in extensive-stage SCLC. The company expects three product launches in China by end of 2024 and up to four NMPA regulatory submissions in the next six months. Cash position was $716.1M as of September 30, 2024.

Gene fusions, particularly NTRK, drive cancer progression and have led to targeted therapies like larotrectinib and entrectinib. These fusions are rare but crucial in specific cancers, with some patients experiencing long-term remissions. Resistance mechanisms and the development of second-generation TRK inhibitors aim to overcome treatment challenges.

Isabel Preeshagul, DO, MBS, emphasizes the importance of shared decision-making in selecting optimal treatment for EGFR-mutated NSCLC, highlighting the expanded options from FLAURA2 and MARIPOSA trials. She discusses the need for patient-centered care, considering comorbidities and treatment tolerability, and the complexities of perioperative vs neoadjuvant approaches without head-to-head comparisons.