AstraZeneca, Daiichi Sankyo collaborate with Summit Therapeutics to evaluate Datroway-ivonescimab combo

Sunvozertinib (Zegfrovy), an oral EGFR inhibitor, is now available in the US for treating EGFR exon 20 insertion-mutated NSCLC after chemotherapy. The FDA approved it based on the WU-KONG1B trial, showing a 46% response rate. AstraZeneca, which markets the drug, highlights its significance for patients with limited treatment options. The drug is also under FDA review for first-line use, with promising phase 3 trial results.

AstraZeneca (AZN) and Daiichi Sankyo (4568.T) announced that their drug Enhertu received conditional approval in China for a new indication. The approval allows the drug to be used in treating a specific type of cancer. This development could expand the market for Enhertu and potentially increase revenue for both companies.

AstraZeneca (AZN) received FDA approval for Ultomiris in IgA nephropathy, showing 43.4% proteinuria reduction. Launched ZEGFROVY for NSCLC with 46% response rate. Filed for first-line approval in U.S. and China. Shares rose ~2.5%. Partnered with Abu Dhabi Biobank for diabetes and cardiovascular disease detection.

AstraZeneca's Ultomiris (ravulizumab) received FDA accelerated approval for treating IgA nephropathy, showing 43.4% greater reduction in urine protein than placebo in a Phase III trial. The approval is based on proteinuria, a marker for kidney damage, with confirmatory trials ongoing. The drug carries a serious infection warning, requiring vaccination before use.

AstraZeneca will start selling sunvozertinib, a lung cancer drug developed by China's Dizal Pharmaceutical, in the US after delays. The FDA approved the drug in July 2025, but it was unavailable in the US for over a year, prompting some Americans to travel to China for treatment.

The NCCN upgraded durvalumab (Imfinzi; AstraZeneca) recommendations in its Esophageal and Esophagogastric Junction Cancers guidelines, moving certain subgroups from category 2B to 2A. The MATTERHORN trial showed improved survival rates with durvalumab plus FLOT. Zanidatamab-hrii combinations were added for HER2-positive adenocarcinoma. Durvalumab plus FLOT was FDA-approved in 2025.