AstraZeneca Q2 core EPS of $2.63 beat consensus, driven by 15% oncology and 8% rare disease growth. The company maintained its 2030 $80 billion revenue target and has more than 20 Phase III readouts expected over the next 18 months.
Clinical trial results support ctDNA-guided therapy for bladder cancer, with the phase III IMvigor011 trial showing improved survival outcomes. Standardisation efforts are underway through position papers from professional societies and consensus guidelines. Nanotechnology advances and AI integration are poised to improve ctDNA detection sensitivity for liquid biopsy applications.
The FDA replaced the two-trial approval requirement with a single pivotal trial standard, launched an AI pilot with AstraZeneca and Amgen, and extended the camizestrant review. A key FDA official is departing. AstraZeneca posted $58.74 billion in revenue.
The FDA extended the review deadline for AstraZeneca's camizestrant and issued a complete response letter for its COPD drug PT010. The agency also adopted a single-pivotal-trial approval policy, while AstraZeneca sold Losec rights to Cheplapharm.
FDA's ODAC voted 6-3 against AstraZeneca's camizestrant for HR+/HER2- metastatic breast cancer, citing uncertain clinical benefit from the SERENA-6 trial design. The FDA raised concerns about the early-switch treatment paradigm and long-term outcomes.
The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07647328 |
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer |
RECRUITING | PHASE3 |
| NCT07427394 |
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer |
RECRUITING | PHASE2 |
| NCT06380751 |
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer |
RECRUITING | PHASE3 |
| NCT06188520 |
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
| NCT05952557 |
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) |
RECRUITING | PHASE3 |
| NCT05774951 |
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy |
RECRUITING | PHASE3 |
