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FDA approves AstraZeneca breast cancer drug Etcamah via accelerated path

Fri, 04 Sep 2026 15:41:44 -0400

The U.S. Food and Drug Administration granted accelerated approval to AstraZeneca's Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer who develop an estrogen receptor-1 (ESR1) mutation during treatment.

According to a statement from the FDA, the approval is based on detection of the ESR1 resistance mutation using an authorized test. ESR1 mutations occur in fewer than 5% of patients at the time of initial HR-positive metastatic breast cancer diagnosis but are present in nearly 40% of patients after disease progression on an aromatase inhibitor.

The FDA described the approval

FDA approves AstraZeneca breast cancer drug Etcamah via accelerated path

Fri, 04 Sep 2026 15:41:44 -0400

The FDA described the approval

BofA Securities Reiterates Buy Rating on AstraZeneca (AZN:LN) (AZN)

Fri, 04 Sep 2026 06:06:35 -0400

BofA Securities analyst Sachin Jain reiterated a Buy rating and GBP165.00 price target on AstraZeneca (AZN:LN) (NASDAQ: AZN).

BofA Securities Reiterates Buy Rating on AstraZeneca (AZN:LN) (AZN)

Fri, 04 Sep 2026 06:06:35 -0400

BofA Securities analyst Sachin Jain reiterated a Buy rating and GBP165.00 price target on AstraZeneca (AZN:LN) (NASDAQ: AZN).

Form 6-K ASTRAZENECA PLC For: Sep 01

Tue, 01 Sep 2026 12:20:00 -0400

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Form 6-K ASTRAZENECA PLC For: Sep 01

Tue, 01 Sep 2026 12:09:00 -0400

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Form 6-K ASTRAZENECA PLC For: Sep 01

Tue, 01 Sep 2026 07:36:00 -0400

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Form 6-K ASTRAZENECA PLC For: Sep 01

Tue, 01 Sep 2026 07:27:00 -0400

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Form 6-K ASTRAZENECA PLC For: Sep 01

Tue, 01 Sep 2026 07:19:00 -0400

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Form 6-K ASTRAZENECA PLC For: Sep 01

Tue, 01 Sep 2026 07:10:00 -0400

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Form 6-K ASTRAZENECA PLC For: Sep 01

Tue, 01 Sep 2026 07:04:00 -0400

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AstraZeneca closes $600M deal for lung cancer drug Zegfrovy

Tue, 01 Sep 2026 07:00:27 -0400

AstraZeneca (LSE/STO/NYSE: AZN) has completed an exclusive global license agreement with Dizal Pharmaceutical Co., Ltd for ZEGFROVY (sunvozertinib), an oral irreversible EGFR inhibitor for non-small cell lung cancer (NSCLC), according to a company statement.

Under the terms of the agreement, AstraZeneca will pay Dizal $600 million upfront, plus up to $900 million in development, regulatory, and sales-related milestone payments. Dizal will also receive tiered royalties on global ZEGFROVY sales. AstraZeneca said the transaction does not affect its financial guidance for 2026.

ZEGFROVY is currently approved in the US and China for second-line treatment of adults with locally advanced or metastatic NSCLC harboring

AstraZeneca completes global license agreement for oral EGFR inhibitor ZEGFROVY® (sunvozertinib) for lung cancer

Tue, 01 Sep 2026 07:00:00 -0400

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca today announced the successful completion of the previously announced exclusive license agreement with Dizal Pharmaceutical Co., Ltd for ZEGFROVY® (sunvozertinib), an oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. Through this agreement, AstraZeneca has acquired worldwide rights to develop and commercialize ZEGFROVY.

ZEGFROVY is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world

AstraZeneca completes global license agreement for oral EGFR inhibitor ZEGFROVY® (sunvozertinib) for lung cancer

Tue, 01 Sep 2026 07:00:00 -0400

EU approves Enhertu combo for first-line HER2-positive breast cancer

Tue, 01 Sep 2026 06:09:45 -0400

The European Commission has approved AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo's (TSE: 4568) Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

The approval is based on results from the DESTINY-Breast09 Phase III trial, which were presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine. In the trial, Enhertu combined with pertuzumab reduced the risk of disease progression or death by 44% compared to a taxane, trastuzumab, and pertuzumab regimen, based on a hazard ratio of 0.56 (95%

EU approves Enhertu combo for first-line HER2-positive breast cancer

Tue, 01 Sep 2026 06:09:45 -0400

EU approves Enhertu combo for first-line HER2-positive breast cancer

Tue, 01 Sep 2026 06:09:45 -0400

AstraZeneca acquires worldwide rights to lung cancer drug Zegfrovy

Tue, 01 Sep 2026 06:09:15 -0400

AstraZeneca (NASDAQ: AZN) has completed an exclusive license agreement with Dizal Pharmaceutical Co., Ltd, giving AstraZeneca worldwide rights to develop and commercialize Zegfrovy (sunvozertinib), an oral irreversible EGFR inhibitor for lung cancer patients.

Zegfrovy is approved in the US and China for second-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations. The drug is already available to patients in China, with a US launch planned for the fourth quarter of 2026.

A supplemental New Drug Application for first-line use has been accepted by the US Food and Drug Administration, supported

AstraZeneca acquires worldwide rights to lung cancer drug Zegfrovy

Tue, 01 Sep 2026 06:09:15 -0400

A supplemental New Drug Application for first-line use has been accepted by the US Food and Drug Administration, supported

AstraZeneca acquires worldwide rights to lung cancer drug Zegfrovy

Tue, 01 Sep 2026 06:09:15 -0400

A supplemental New Drug Application for first-line use has been accepted by the US Food and Drug Administration, supported

AstraZeneca's Tagrisso combo shows Phase III benefit in lung cancer

Tue, 01 Sep 2026 06:08:28 -0400

AstraZeneca (NASDAQ: AZN) announced positive high-level results from the SANOVO Phase III trial, showing that Tagrisso (osimertinib) combined with Orpathys (savolitinib) produced a statistically significant improvement in progression-free survival (PFS) compared with Tagrisso alone in treatment-naïve patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) and MET overexpression.

The PFS benefit was observed in both the high MET (IHC 3+) and the intention-to-treat (ITT) trial populations (IHC 2+ and IHC 3+). The combination also showed clinical benefit in overall survival (OS), a secondary endpoint, in both patient populations. The trial will continue to follow

AstraZeneca's Tagrisso combo shows Phase III benefit in lung cancer

Tue, 01 Sep 2026 06:08:28 -0400

AstraZeneca's Tagrisso combo shows Phase III benefit in lung cancer

Tue, 01 Sep 2026 06:08:28 -0400

Enhertu® Plus Pertuzumab Approved in the EU as First New Regimen in More than a Decade for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

Tue, 01 Sep 2026 02:30:00 -0400

Approval based on DESTINY-Breast09 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
Second approval for Enhertu in the EU in two months

TOKYO--(BUSINESS WIRE)-- Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer.

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered

Enhertu® Plus Pertuzumab Approved in the EU as First New Regimen in More than a Decade for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

Tue, 01 Sep 2026 02:30:00 -0400

Approval based on DESTINY-Breast09 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
Second approval for Enhertu in the EU in two months

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered