Elevar Therapeutics Inc. said that the U.S. FDA accepted its NDA for oral tyrosine kinase inhibitor rivoceranib in combination with PD-1 inhibitor camrelizumab (Airuika) as a first-line treatment for liver cancer. The FDA stamped an official PDUFA target action date of May 16, 2024.
Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm characterized by a chromosomal translocation that results in the generation of the BCR-ABL1 oncogene, which encodes the chimeric BCR-ABL1 protein with tyrosine kinase activity. Allosteric tyrosine kinase inhibitors (TKIs) represent an improvement of 2-fold in efficacy over standard inhibitors and are better tolerated.
Acea Therapeutics Inc. and Hangzhou Acea Biosciences Co. Ltd. have described heterocyclic compounds acting as tyrosine kinase inhibitors reported to be useful for the treatment of cancer.
Beijing Guohong Biomedical Technology Co. Ltd. has presented new inhibitors of proto-oncogene tyrosine-protein kinase Src, hepatocyte growth factor receptor and more.
Idrx Inc. launched with a $122 million oversubscribed series A round to boost precision drug combinations in cancer, with a first focus on non-PDGFR-driven gastrointestinal stromal tumors (GIST). The Plymouth, Mass.-based firm aims to develop a pairing, potentially with add-ons, powerful enough to handle existing mutations and those that turn up during treatment. Combo therapy attacks “not just the driver mutations, but also the key secondary mutations,” co-founder and CEO Ben Auspitz told BioWorld, and thereby “block every escape route the cancer has.”
Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.
Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.
China’s National Medical Products Administration (NMPA) gave the green light to Pfizer Inc.’s third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena (lorlatinib), for patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).
Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer.
Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer.
