Drugmaker AstraZeneca Plc chalked up two regulatory wins on Tuesday, with approvals in both the US and Europe for key treatments in oncology and immunology.
AstraZeneca said Enhertu, developed in conjunction with Daiichi Sankyo, had received US Food and Drug Administration approval in combination with pertuzumab for the first‑line treatment of HER2‑positive metastatic breast cancer - marking the first new therapy in the category in a decade.
The FTSE 100-listed firm said approval was based on the DESTINY‑Breast09 trial, which showed a 44% reduction in the risk of disease progression or death, with median progression‑free survival exceeding three years compared to the standard THP regimen. The decision also triggered a $150m milestone payment from AstraZeneca to Daiichi Sankyo.
Separately, AstraZeneca said its lupus therapy Saphnelo had been cleared in the European Union for subcutaneous self‑administration via a pre‑filled pen, offering patients the same clinical benefits as intravenous infusion with greater convenience.
The approval was supported by positive phase III TULIP‑SC trial data, which demonstrated a significant reduction in disease activity. AZN added that sales of Saphnelo will be subject to a low‑to‑mid‑teens royalty payable to Bristol‑Myers Squibb, depending on geography.
As of 0855 GMT, AstraZeneca shares were up 0.53% at 13,684p.
Reporting by Iain Gilbert at Sharecast.com