AstraZeneca Gets FDA Approval for New Breast Cancer Drug, Posts Positive Lung Cancer and COPD Data

On Tuesday, AstraZeneca received a key approval from the U.S. Food and Drug Administration for a new breast cancer treatment, while also posting positive Phase 3 trial data for its lung cancer and respiratory therapies.

Lung Cancer Trial Success

On Tuesday, the company announced interim results from its DeLLphi-305 Phase 3 trial.

The study evaluated patients with extensive-stage small cell lung cancer whose disease had stabilized after standard induction therapy.

Data showed that combining Imfinzi with Amgen's Imdelltra as first-line maintenance therapy significantly improved overall survival compared with Imfinzi alone.

The combination also demonstrated meaningful improvements in progression-free survival and objective response rate.

Respiratory Treatment Progress

AstraZeneca also released full results from its OBERON and TITANIA Phase 3 trials evaluating tozorakimab for chronic obstructive pulmonary disease.

The trials showed that tozorakimab effectively reduced moderate and severe exacerbations across a broad patient population.

In these trials, tozorakimab reduced exacerbations by 30% and 29% versus placebo in the overall population, respectively. Researchers also noted that the biologic reduced mucus plugging.

The FDA has accepted the Biologics License Application for tozorakimab and granted Priority Review, with a target action date set for the first quarter of 2027.

FDA Accelerated Approval for Breast Cancer Drug

Last Friday, the U.S. Food and Drug Administration granted accelerated approval to AstraZeneca's Etcamah in combination with a CDK4/6 inhibitor.

The approval covers adult patients with HR-positive, HER2-negative metastatic breast cancer harboring ESR1 mutations.

The authorization was based on the pivotal SERENA-6 Phase 3 trial, in which the Etcamah combination reduced the risk of disease progression or death by 56% versus standard of care.

Patients treated with Etcamah achieved a median progression-free survival of 16.0 months, versus 9.2 months for the standard-of-care group.

AZN Stock Movement: As of Tuesday's writing, AstraZeneca shares were down 0.74% at $161.49.