Savolitinib

China's NMPA granted breakthrough therapy designation to savolitinib and osimertinib for EGFR-mutant, MET-amplified NSCLC post-EGFR inhibitor therapy. The combination is being evaluated in the phase 3 SACHI trial vs platinum-doublet chemotherapy. Eligibility includes EGFR sensitizing mutations, MET amplification, and measurable lesions. The primary endpoint is investigator-assessed PFS, with secondary endpoints including overall survival and safety. The FDA also granted fast track designation to the combination in 2023.

HUTCHMED announces NMPA's Breakthrough Therapy Designation for ORPATHYS® and TAGRISSO® combo in EGFR mutation-positive NSCLC with MET amplification post-EGFR inhibitor therapy. The combination is being evaluated in China's Phase III SACHI trial, comparing its efficacy and safety to standard-of-care platinum-based doublet-chemotherapy.

HUTCHMED announces NMPA granted Breakthrough Therapy Designation to ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for EGFR mutation-positive NSCLC with MET amplification after EGFR inhibitor therapy. The combination is being evaluated in the Phase III SACHI trial in China.

HUTCHMED announces NMPA's Breakthrough Therapy Designation for ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) combo in EGFR mutation-positive NSCLC with MET amplification. The treatment is being evaluated in China's Phase III SACHI trial, comparing its efficacy and safety to standard platinum-based chemotherapy. NMPA grants BTD to therapies addressing life-threatening diseases with significant advantages over existing treatments, potentially expediting development and review.

Hutchmed China announced NMPA granted breakthrough therapy designation to Orpathys and Tagrisso for EGFR mutation-positive NSCLC with MET amplification. The combination is being investigated in the phase three SACHI trial in China, comparing its efficacy and safety against standard platinum-based chemotherapy. BTD status aims to expedite development and review, potentially accelerating treatment availability for patients.

HUTCHMED announces NMPA's Breakthrough Therapy Designation for ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) combo in EGFR mutation-positive NSCLC with MET amplification. The treatment is being evaluated in China's Phase III SACHI trial, comparing its efficacy and safety to standard-of-care platinum-based doublet-chemotherapy.

Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation in the US for treating EGFRm NSCLC progressing after EGFR-TKI and platinum-based chemotherapy. The FDA granted this based on TROPION-Lung05 Phase II and TROPION-Lung01 Phase III trial data, presented at ESMO Asia 2024. Datopotamab deruxtecan, a TROP2-directed ADC, is jointly developed by AstraZeneca and Daiichi Sankyo, with potential to address significant unmet needs in EGFRm NSCLC treatment.

AstraZeneca's Imfinzi approved in the US for limited-stage small cell lung cancer (LS-SCLC) after chemotherapy and radiation, based on ADRIATIC trial results showing improved survival and reduced risk of death and disease progression.