AstraZeneca Seeks US Approval for Lung Cancer Drug Combination

AstraZeneca has asked the FDA to approve ORPATHYS with TAGRISSO for certain patients with advanced lung cancer. Trial results support the application, while the US regulator’s decision remains the next key step.

AstraZeneca and HUTCHMED have taken another step toward bringing a lung cancer treatment combination to the US market.

AstraZeneca has applied to the Food and Drug Administration for approval of ORPATHYS alongside TAGRISSO for patients with advanced lung cancer whose disease progressed after earlier EGFR-targeted treatment.

According to HUTCHMED, the combination extended the time patients lived without their cancer worsening and improved overall survival compared with chemotherapy. ORPATHYS is jointly developed by the two companies and commercialised by AstraZeneca.

The application matters to investors because it could expand the reach of an existing AstraZeneca cancer medicine while creating a US opportunity for its partner’s drug. ORPATHYS has already received approval in China based on a separate late-stage study.

The US decision is still ahead. Investors will now watch the FDA review and the eventual terms of any approval before judging the size of the commercial opportunity.