FDA ap­proves As­traZeneca’s oral SERD for breast can­cer de­spite neg­a­tive ad­comm vote

Citi highlights AstraZeneca's accelerated FDA approval for Etcamah (camizestrant) as a positive for its shares. The drug, for metastatic breast cancer, was approved with a CDK4/6 inhibitor. Citi expects $450M from SERENA-6, down to $112M risk-adjusted, and a $6B opportunity from SERENA-4. A failure would still leave a $1.5B opportunity.

AstraZeneca AZN received FDA approval for Etcamah, a breast cancer therapy, in combination with CDK4/6 inhibitors from Pfizer PFE, Novartis NVS, and Eli Lilly LLY. The approval, supported by the SERENA-6 study, shows a 56% reduction in disease progression or death. This is AstraZeneca's 10th FDA approval this year and its fourth for breast cancer. The FDA also approved a companion diagnostic test by Guardant Health.

The FDA approved AstraZeneca's Etcamah combo for advanced breast cancer with ESR1 mutations. The approval is based on the SERENA-6 trial, showing a 56% reduction in disease progression or death risk. Median progression-free survival was 16.0 months vs. 9.2 months. The FDA also approved a companion diagnostic for detecting ESR1 mutations. AstraZeneca's Dave Fredrickson highlighted the approval as the company's fourth in breast cancer this year.

AstraZeneca's ETCAMAH (camizestrant) in combination with a CDK4/6 inhibitor received US approval for 1st-line advanced HR-positive breast cancer. The FDA approval was based on the SERENA-6 Phase III trial, which showed a 56% reduction in disease progression or death risk. The combination is the first of its type in the 1st-line setting, according to AstraZeneca. The approval includes a companion diagnostic test to detect ESR1 mutations in circulating tumor DNA. AstraZeneca has received ten FDA a

The FDA approved AstraZeneca's camizestrant (Etcamah) for advanced breast cancer, triggered by a blood test detecting ESR1 mutations. The drug, used with CDK4/6 inhibitors, showed 16-month median progression-free survival in trials. The approval is conditional, pending confirmatory studies on overall survival benefits. The FDA also authorized the Guardant360 CDx test for detecting ESR1 mutations. The drug carries warnings for heart rhythm issues and fetal harm.

AstraZeneca's breast cancer drug, camizestrant (brand name Etcamah), received FDA approval for use in metastatic breast cancer patients with a specific genetic mutation. The drug is expected to generate over $5 billion in annual sales, according to the company, but analysts predict lower figures. The FDA's approval follows an earlier advisory panel vote against the medicine.