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FDA Grants Breakthrough Therapy Designation to JNJ-6372 in Metastatic Non-Small Cell Lung Cancer

*March 2020* The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-6372 to Janssen Pharmaceutical, a Johnson & Johnson Company. NJ-6372 is an investigational treatment for metastatic non-small cell lung cancer (mNSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations. It has been approved…

Tumor Analyses Reveal Squamous Transformation and Off-Target Alterations As Early Resistance Mechanisms to First-line Osimertinib in EGFR-Mutant Lung Cancer

*January 2020* Among 62 patients who met eligibility critieria, histologic transformation, primarily squamous transformation, was identified in 15% of first-line osimertinib cases and 14% of later-line cases. Nineteen percent (5/27) of patients treated with first-line osimertinib had off-target genetic resistance (2 MET amplification, 1 KRAS mutation, 1 RET fusion, and…
Onc Live

FDA Grants Priority Review to Capmatinib in METex14+ NSCLC

*February 2020* Positive news for METex14 mutated NSCLC patients. Note this is also good news for patients with EGFR-Independent acquired resistance after osimertinib. (Mesenchymal epithelial transition (MET) amplification is a common mechanism of resistance to EGFR-TKI treatment, bserved in ~20-30% of EGFR-mutant NSCLC after osimertinib.) Reuters reports the FDA has…