FDA Receives BLA for Ivonescimab Plus Chemo in Second-Line or Later EGFR-Mutant NSCLC

OncLive·Jan 12

✦ NabkaNews BriefAuto-summarized from multiple outlets · verify with the source

The FDA has received a biologics license application for ivonescimab in combination with chemotherapy for the treatment of EGFR-mutant non-small cell lung cancer. The application appears to be for use in patients who have received prior treatment, although the specific details of the intended patient population are not consistent across reports. The submission has been accepted for review, but the outcome is uncertain.

Full coverage

FDA Receives BLA for Ivonescimab Combo in Advanced/Metastatic EGFR+ NSCLC

CancerNetwork·Jan 13

FDA Receives BLA for Ivonescimab in EGFR+ NSCLC

Targeted Oncology·Jan 13

FDA Accepts BLA for Ivonescimab Plus Chemotherapy in EGFR-Mutated NSCLC After TKI Therapy

Oncodaily·Jan 31

Summit Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA Seeking Approval for Ivonescimab in Combination with Chemotherapy in 2L+ Treatment of Patients with EGFRm NSCLC

BioSpace·Jan 12

Fetching the latest headlines…

FDA Receives BLA for Ivonescimab Plus Chemo in Second-Line or Later EGFR-Mutant NSCLC

Full coverage

FDA Receives BLA for Ivonescimab Combo in Advanced/Metastatic EGFR+ NSCLC

FDA Receives BLA for Ivonescimab in EGFR+ NSCLC

FDA Accepts BLA for Ivonescimab Plus Chemotherapy in EGFR-Mutated NSCLC After TKI Therapy

Summit Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA Seeking Approval for Ivonescimab in Combination with Chemotherapy in 2L+ Treatment of Patients with EGFRm NSCLC

FDA starts review clock for Summit, Akeso's PD-1/VEGF bispecific

FDA Accepts BLA for Ivonescimab in Pretreated EGFR-Mutated NSCLC

Ivonescimab Plus Chemo Meets PFS End Point in EGFR+ NSCLC After an EGFR TKI

Don't Buy Summit Therapeutics Until This Big Thing Happen