AstraZeneca PLC Sponsored ADR (AZN.US) heavyweight breast cancer new drug approved for listing in the European Union

On July 23rd, Astrazeneca PLC Sponsored ADR (AZN.US) announced that its Etcamah (camizestrant) in combination with cyclin-dependent kinase (CDK) 4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) has been approved in the EU for the treatment of adult patients with locally advanced or metastatic estrogen receptor (ER) positive, HER2 negative breast cancer, who have detected ESR1 mutation and have not experienced disease progression during first-line endocrine therapy combined with CDK4/6 inhibitor treatment. Astrazeneca PLC Sponsored ADR stated that Etcamah is currently the only new generation oral SERD approved for first-line treatment of breast cancer. Previously, the product has been approved and launched in Japan, the UAE, and Saudi Arabia, with applications for approval also submitted in regions such as the United States. This approval is based on the positive results from the pivotal Phase III SERENA-6 study. This was a randomized, double-blind, global, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Etcamah in combination with CDK4/6 inhibitors in patients with HR-positive, HER2-negative advanced breast cancer. In a pre-specified interim analysis, Etcamah in combination with AI and CDK4/6 inhibitors significantly reduced the risk of disease progression or death by 56% compared to standard treatment (HR 0.44; 95% CI: 0.31-0.60; p<0.00001), with a median progression-free survival (PFS) of 16 months compared to 9.2 months in the control group. Updated data presented at the 2026 ASCO meeting showed a 99% decrease in median total ctDNA change at week 8 after switching to Camizestrant, while the control group continuing AI+CDK4/6 showed a 64% increase. In terms of safety, the combination regimen had consistent safety profiles with each individual drug. No new safety concerns were identified, and the discontinuation rates in both groups were very low and similar. It is worth noting that in April 2026, the U.S. FDA ODAC did not support the approval of Etcamah with a vote of 3:6, as they believed the existing clinical data did not confirm that switching medications before radiographic progression could provide substantial and clinically meaningful long-term benefits for patients. The FDA then extended the PDUFA date to review additional supplemental data.