AstraZeneca and Johnson & Johnson advance new cancer treatments

AstraZeneca has submitted an application to the U.S. Food and Drug Administration (FDA) for the combination of Orpathys (savolitinib) and Tagrisso (osimertinib). This treatment is intended for patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit MET overexpression or amplification following progression on an EGFR tyrosine kinase inhibitor.

The regulatory request is supported by the Phase III SAFFRON clinical trial, which involved 338 patients across 29 countries. The study demonstrated statistically significant improvements in progression-free and overall survival compared to platinum-based chemotherapy. This combination aims to address MET-driven resistance, which occurs in approximately 34% of tumors after progressing with third-generation EGFR inhibitors.

Separately, Johnson & Johnson announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecvayli (teclistamab) for adults with relapsed or refractory multiple myeloma (RRMM). The recommendation follows the Phase III MajesTEC-9 study, which showed significant improvements in progression-free and overall survival compared to standard treatments in patients who had previously received one to three lines of therapy.