Breast Cancer

Breast Cancer Statistics Worldwide: What the Data Shows

Breast cancer remains the most common cancer in women across many markets, with 2.3 million new cases estimated globally each year. This plan frames the latest data for pharma teams, including age distribution, lifetime risk, and U.S. trend signals.

FDA Approves Companion Diagnostic for Inavolisib in HR+/HER2–, PIK3CA-Mutated Breast Cancer

The FDA has approved FoundationOne CDx as a companion diagnostic for inavolisib (Itovebi) in combination with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. This approval expands the targeted therapy landscape and underscores the importance of genomic testing in patient selection.

FDA Flashback: Key Breast Cancer Decisions from April 2026

April 2026 brought pivotal FDA actions in breast cancer, including an ODAC split vote on AstraZeneca's candidate and a breakthrough device designation. This article analyzes the decisions, their competitive impact, and what pharma teams should watch next.

AstraZeneca and Daiichi's Datroway (Dato-DXd) Approved for Triple-Negative Breast Cancer: Implications for Pharma

The FDA approved AstraZeneca and Daiichi Sankyo's Datroway (Dato-DXd) as a first-line treatment for triple-negative breast cancer on May 1, 2026. This article provides key takeaways, regulatory details, and strategic implications for pharma decision-makers.

AstraZeneca's Camizestrant: Navigating Divergent Regulatory Paths for Breast Cancer Treatment

AstraZeneca's breast cancer drug, camizestrant, faced a significant regulatory divergence with CHMP approval in Europe contrasting with an FDA rejection. This split highlights evolving global regulatory landscapes and presents key considerations for pharmaceutical business development and investment strategies.

FDA Approves Generic Eribulin Mesylate for Metastatic Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved an abbreviated new drug application (ANDA) for generic eribulin mesylate injection. This approval offers a new therapeutic option for patients with pretreated metastatic breast cancer and unresectable or metastatic liposarcoma.

FDA Grants Priority Review to Giredestrant for ER+/HER2- Breast Cancer

The FDA has granted Priority Review to Roche's investigational oral SERD, giredestrant, for the adjuvant treatment of ER+/HER2- breast cancer. This decision is based on Phase III data demonstrating a significant reduction in recurrence risk.

Celcuity's Gedatolisib: Navigating the Path to Broad FDA Approval in Breast Cancer

Celcuity has announced positive topline data from its Phase 3 VIKTORIA-1 trial for gedatolisib in breast cancer, positioning the company for a broad FDA filing. This development marks a significant catalyst for the company and the broader oncology landscape.