AstraZeneca PLC submits US NDA for Orpathys plus Tagrisso

A new U.S. approval request for a lung cancer combination reached the FDA, as AstraZeneca PLC LONAZN NYSEAZN submitted an application for Orpathys plus Tagrisso, partner HUTCHMED said Tuesday. The request rests on a 338-patient Phase 3 trial that HUTCHMED says improved both progression-free and overall survival against chemotherapy.

The new drug application seeks approval for patients with locally advanced or metastatic non-small cell lung cancer whose tumours show MET overexpression or amplification after disease progression on or after EGFR inhibitor treatment. That is a request for a biomarker-selected treatment after earlier targeted therapy, not an FDA approval or an announced review deadline.

AstraZeneca is a Cambridge-based global drugmaker, while HUTCHMED (China) Limited HKG13 NASDAQHCM develops cancer medicines with a commercial presence in China.

AstraZeneca's New York shares NYSEAZN closed Monday at US$166.15 as of 4:00:03 p.m. EDT. HUTCHMED's Nasdaq shares NASDAQHCM closed Monday at US$14.13 as of 4:00:01 p.m. EDT. The issuer release appeared at 8 p.m. ET Monday, so both closes precede the announcement and establish baselines rather than a reaction to it.

SAFFRON Tested the Combination Against Chemotherapy

The SAFFRON study enrolled 338 patients with MET overexpression or amplification after first- or second-line Tagrisso. The randomized, open-label trial compared Orpathys plus Tagrisso with doublet platinum-based chemotherapy and ran at 230 centres across 29 countries, according to HUTCHMED's Sept. 29 announcement.

Progression-free survival was the primary endpoint, with overall survival a key secondary measure. HUTCHMED says the combination improved both outcomes with statistical significance, but its filing announcement gives no medians, hazard ratios, p values or confidence intervals. Without those figures, the size of the benefit against chemotherapy cannot yet be assessed from the notice.

HUTCHMED said the combination's safety profile was consistent with the known profiles of each medicine. Its Sept. 29 release did not provide adverse-event rates or a breakdown by treatment arm.

"This filing is an important step toward potentially bringing ORPATHYS® plus TAGRISSO® to patients in the US, after its approval in China based on the SACHI Phase III trial."

HUTCHMED acting chief executive and chief financial officer Johnny Cheng said this in the company release. The Chinese approval covers a different specified group: EGFR-mutated, non-squamous lung cancer with MET amplification after EGFR inhibitor therapy. The U.S. application also refers to MET overexpression, so the two descriptions should not be treated as identical.

HUTCHMED Reports No FDA Review Date

The FDA describes a general 60-day filing period for new drug applications. HUTCHMED's Sept. 29 release does not report FDA acceptance, a review designation or a target action date, and gives no FDA receipt date from which to calculate a filing-period deadline.

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Orpathys is jointly developed by AstraZeneca and HUTCHMED but commercialized by AstraZeneca, the partners said. Tagrisso is already approved in the United States as a stand-alone treatment in several lung cancer settings and with chemotherapy in the first-line metastatic setting. A new authorization would extend its use into the post-EGFR inhibitor, MET-selected setting covered by this application.

That division of roles gives holders of AstraZeneca and HUTCHMED exposure to the same FDA review through different businesses. The release gives no U.S. sales forecast, launch price or division of any prospective sales receipts, so the revenue effect cannot be quantified from the application announcement.

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The next announced data event is a presentation of SAFFRON results at a Presidential Symposium during the 2026 European Society for Medical Oncology Congress.