EGFR exon 20 insertion mutations Archives

Cullinan Oncology and Taiho reunite to co-develop NSCLC drug

Acquisitions, Biopharma Companies, Business, Collaborations, EGFR exon 20 insertion mutations, EGFR tyrosine kinase inhibitors (TKI), Licensing, Non-Small Cell Lung Cancer, R&D, R&D, Taiho Pharmaceutical

Cullinan Oncology and Taiho Pharmaceutical announced that Taiho was acquiring Cullinan Pearl and will co-develop and co-commercialize a non-small cell lung cancer (NSCLC) drug.

Takeda’s Exkivity Approved by U.S. FDA as First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+ NSCLC

Adults, Approvals, Clinical Trials, EGFR exon 20 insertion mutations, FDA, Metastatic non-small cell lung cancer, Next-Generation Sequencing (NGS), Platinum-Based Chemotherapy, R&D, Takeda, Therapeutics

The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Rybrevant Receives U.S. FDA Approval

Approvals, Bispecific Antibody, Companion Diagnostics, EGFR exon 20 insertion mutations, Epidermal Growth Factor Receptor (EGFR), FDA, First-In-Class, Janssen, Johnson & Johnson, Lung Cancer, New Drug Approvals, Non-Small Cell Lung Cancer, Therapeutics

The U.S. Food and Drug Administration granted accelerated approval of Janssen’s Rybrevant (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.