Targeted News Service

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.

The FDA approved AstraZeneca's breast cancer pill, Etcamah, for a specific form of metastatic breast cancer, despite earlier advisory committee concerns. The approval, based on trial results, offers patients an additional treatment option. AstraZeneca projects potential annual sales of over $5 billion. The drug is already approved in over 30 countries.

AstraZeneca's ETCAMAH® (camizestrant) in combination with a CDK4/6 inhibitor received FDA approval for 1st-line advanced HR-positive breast cancer. The approval was based on the SERENA-6 Phase III trial, which showed a 56% reduction in the risk of disease progression or death. The treatment is the first of its type in the 1st-line setting and has the potential to reshape treatment paradigms for this form of advanced breast cancer. AstraZeneca has received its tenth FDA approval this year, with f

Guardant Health (GH) received FDA approval for Guardant360 CDx as a companion diagnostic for AstraZeneca's ETCAMAH in advanced breast cancer. The approval, based on the SERENA-6 trial, showed a 56% reduction in disease progression risk when using ctDNA-guided treatment. The test is recommended for use every three months during therapy.

The FDA granted accelerated approval to AstraZeneca's Etcamah (camizestrant) for treating advanced breast cancer with ESR1 mutations. The approval was based on a clinical trial showing 16-month median progression-free survival. The FDA required confirmatory studies to verify clinical benefit. The approval includes a companion diagnostic test, Guardant360 CDx, for identifying eligible patients.

Ionis (IONS) and Milestone (MIST) gained FDA approvals for neurology and cardiology drugs. Biogen (BIIB) and AstraZeneca (AZN) also received regulatory nods for Alzheimer's and cancer treatments. Novavax (NVAX) secured global approvals for its COVID-19 vaccine. TScan (TCRX) and Novartis (NVS) announced job cuts. Novartis (NVS) and HUTCHMED (HCM) struck deals worth up to $3.2B and $1.295B respectively.