Repotrectinib

The 2024 NCCN Breast Cancer guidelines update includes ribociclib plus an aromatase inhibitor as a preferred regimen for HR-positive, HER2-negative early breast cancer. Ribociclib is the only category 1 CDK4/6 inhibitor for first-line treatment in combination with an AI. The guidelines also add adjuvant ribociclib for premenopausal patients with HR-positive, HER2-negative disease, and revise other treatment pathways. The FDA approval of adjuvant ribociclib may apply to a wider population than abemaciclib, with ribociclib given at 400 mg for 3 years, compared to abemaciclib's 2 years.

Lung cancer, primarily non-small cell lung cancer (NSCLC), is a leading cause of morbidity and mortality globally. Targeted therapies have emerged as a preferred first-line treatment for NSCLC patients with oncogenic driver mutations, such as EGFR, ALK, ROS1, BRAF, MET, RET, FGFR, and NTRK. These therapies, including small-molecule drugs and monoclonal antibodies, have shown superior efficacy compared to traditional chemotherapy and immunotherapy, particularly in specific molecular subtypes. Challenges remain in drug resistance, adverse effects, and determining optimal treatment sequences. Continued research is essential for advancing precision medicine in lung cancer treatment.

EMA's CHMP recommended repotrectinib (Augtyro) approval for advanced ROS1-positive NSCLC and NTRK fusion-positive solid tumors, supported by TRIDENT-1 and CARE trials showing durable activity and robust responses. The drug received FDA approval in 2023 and accelerated approval in 2024.

EMA CHMP recommends approval of Opdivo plus Yervoy for first-line treatment of MSI-H/dMMR unresectable or metastatic colorectal cancer, based on CheckMate -8HW trial results showing significant PFS improvement and manageable safety profile.

Bristol Myers Squibb announced CHMP's recommendation for repotrectinib approval for ROS1-positive advanced NSCLC and NTRK-positive solid tumours. The EC will review the recommendation, with a decision expected in January 2025. Repotrectinib demonstrated clinically meaningful response rates in TRIDENT-1 and CARE trials, with a manageable safety profile.

FDA receives BLA for Dato-DXd in EGFR+ advanced NSCLC; RP1 plus nivolumab shows activity in advanced melanoma post-PD-1 therapy; 177Lu-PSMA-I&T meets rPFS endpoint in PSMA+ mCRPC; refined platinum resistance definition and novel ADCs impact ovarian cancer treatment; CHMP recommends isatuximab plus VRd for transplant-ineligible myeloma; CHMP also supports repotrectinib, pembrolizumab plus chemo, nivolumab plus ipilimumab, and denosumab biosimilars.

CHMP recommends repotrectinib (Augtyro) for ROS1-positive advanced NSCLC and NTRK-positive solid tumors, based on TRIDENT-1 and CARE trials showing clinically meaningful ORRs. EC review expected by January 2025. FDA approved repotrectinib for ROS1-positive NSCLC in 2023 and NTRK-positive solid tumors in 2024, both supported by TRIDENT-1 data.

Bristol Myers Squibb announced CHMP's recommendation for repotrectinib approval for ROS1-positive advanced NSCLC and certain solid tumors, under EC review for Jan 2025 decision. Based on TRIDENT-1 and CARE trials, repotrectinib showed meaningful response rates and durable activity, with manageable safety profile. Previously approved in the U.S., repotrectinib targets ROS1 and NTRK fusions in advanced solid tumors. Bristol-Myers Squibb also saw analyst upgrades, FDA approval for Cobenfy, and acquisition of Karuna Therapeutics for growth portfolio expansion.

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.