AstraZeneca caps milestone week with FDA nod, COPD data

AstraZeneca ↘ 1.15% secured accelerated FDA approval for its breast cancer drug Etcamah (camizestrant), capping a week of clinical milestones for the British-Swedish drugmaker that included positive late-stage data for a COPD treatment it expects could generate more than $5 billion in annual sales.

A Landmark Approval Over Advisory Panel Objections

The FDA granted accelerated approval to Etcamah on September 4, authorizing the oral estrogen receptor antagonist in combination with a CDK4/6 inhibitor for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who develop ESR1 mutations during first-line treatment. The decision came despite an earlier vote against the drug by the FDA's Oncologic Drugs Advisory Committee, which had found insufficient evidence of "meaningful benefit".fda+3

The approval was based on the Phase 3 Serena-6 trial, in which Etcamah plus a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% compared to standard-of-care treatment. Median progression-free survival reached 16 months in the Etcamah arm versus 9.2 months in the control group. As Fierce Pharma reported, the approval opens a new treatment paradigm in which patients are monitored for emerging ESR1 mutations through circulating tumor DNA testing and switched to Etcamah before their disease visibly progresses on scans.fiercepharma+2

AstraZeneca has said Etcamah has the potential to eventually bring in more than $5 billion in annual sales.latimes

COPD Drug Tozorakimab Delivers Strong Phase 3 Results

On Tuesday, AstraZeneca also released full results from its Phase 3 OBERON and TITANIA trials of tozorakimab for chronic obstructive pulmonary disease. The drug reduced moderate-to-severe COPD exacerbations by 29% to 34% in former smokers compared to placebo, with benefits extending across patients regardless of blood eosinophil counts. The data, published simultaneously in the New England Journal of Medicine and presented at the European Respiratory Society Congress in Barcelona, showed tozorakimab is the first biologic to demonstrate broad efficacy across COPD patient populations still experiencing flare-ups on inhaled therapies. The drug is under FDA priority review, with U.S. approval expected in the first quarter of 2027.statnews+2

A Reassuring Stretch for AstraZeneca

The twin developments arrive at a welcome moment for AstraZeneca, which has faced some recent clinical setbacks, most notably with a heart disease drug. As STAT reported, the tozorakimab results "amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months".statnews