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FDA Issues CRL for SC Amivantamab BLA in EGFR+ NSCLC
FDA Issues CRL for SC Amivantamab BLA in EGFR+ NSCLC

December 18th 2024

The FDA issued a complete response letter for the BLA submission of subcutaneous amivantamab for EGFR-mutated NSCLC, citing manufacturing inspection issues, but confirming no need for additional clinical trials.

FDA Grants Breakthrough Status to Sacituzumab Tirumotecan in EGFR+ NSCLC
FDA Grants Breakthrough Status to Sacituzumab Tirumotecan in EGFR+ NSCLC

December 4th 2024

FDA Approval Sought for Dato-DXd in EGFR-Mutated NSCLC
FDA Approval Sought for Dato-DXd in EGFR-Mutated NSCLC

November 14th 2024

FDA Clears Amivantamab/Chemotherapy Combo in EGFR-Mutant NSCLC
FDA Clears Amivantamab/Chemotherapy Combo in EGFR-Mutant NSCLC

September 20th 2024

Zipalertinib Shows Promise in Heavily Pretreated EGFR Exon 20-Mutated NSCLC
Zipalertinib Shows Promise in Heavily Pretreated EGFR Exon 20-Mutated NSCLC

September 14th 2024

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