FDA approved AstraZeneca’s durvalumab (Imfinzi) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer.
In the continuing evolution of personalized medicine, a new Yale study has found evidence to support the value of a tool that measures the presence of cancer-derived molecules in the blood of patients with lung cancer years after their treatment.
Positive results from the NIAGARA phase III trial showed Imfinzi (durvalumab)in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of overall survival versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer.
Updated results from the HIMALAYA phase III trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival benefit at five years for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.
FDA granted priority review for Imfinzi (durvalumab), AstraZeneca’s supplemental Biologics License Application, based on the results from the positive ADRIATIC phase III trial in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.
Positive high-level results from an interim analysis of the AMPLIFY phase III trial showed a fixed duration of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia.
Detailed positive results from the DESTINY-Breast06 phase III trial showed that Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care chemotherapy in patients with HR-positive, HER2-low metastatic breast cancer and the overall trial population (patients with HR-positive, HER2-low and HER2-ultralow [defined as IHC 0 with membrane staining] expression) following one or more lines of endocrine therapy.
Positive high-level results from the DESTINY-Breast06 phase III trial showed that Enhertu (fam-trastuzumab deruxtecan-nxki) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care chemotherapy in the primary trial population of patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer following one or more lines of endocrine therapy.
FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors
FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Positive results from the EMERALD-1 phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with transarterial chemoembolization, or TACE, and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival compared to TACE alone in patients with hepatocellular carcinoma eligible for embolization.
