DATROWAY® approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer
DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
Global Oncology Breakthroughs Being Fueled by Advancements in Clinical Trials and New TherapiesPALM BEACH, Fla., July 08, 2025 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - The global oncology market, including breakthrough treatments, is experiencing substantial growth, with revenues projected to reach hundreds of billions of dollars in the coming years. Several factors are driving this expansion, including rising cancer incidence, advancements in therapies like precision medicine and immunotherapy, and increased investment in research and development. A report from Grand View Research said that the global breakthrough therapy designation market size is projected to grow at a CAGR of 14.2% through 2030. It is a process designed to escalate the development and assessment of sanctioning of drugs & biologics that are proposed for treating severe diseases, whereas primary clinical evidence notifies that the drug determines considerable enhancement over existing therapy on a clinically significant endpoint. Furthermore, the BT (Breakthrough) designation lets pharma companies hasten the developmental process by offering additional support and assistance from the FDA and making medications available to the public faster. The report continued: “Apart from breakthrough designation therapy, there are some important tools, all of which have been in place for many years, such as fast-track designation, accelerated approval, and priority review. All of these are inclined toward approving drugs used to treat serious disorders. Although these processes can reduce a drug's time to market, standard clinical testing is required for the development process, which usually involves three phases of large-scale and controlled trials.” Active oncology biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (
NASDAQ: ONCY) (TSX: ONC), Mustang Bio, Inc. (
NASDAQ: MBIO), Verastem Oncology (
NASDAQ: VSTM), Cardiff Oncology, Inc. (
NASDAQ: CRDF), AstraZeneca PLC (
NASDAQ: AZN).
ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP as 1st-line therapy in patients with HER2-positive metastatic breast cancer in DESTINY-Breast09 Phase III trial
Positive results from the DESTINY-Breast09 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer.
IMFINZI® (durvalumab) regimen reduced risk of progression, recurrence or death by 29% in early-stage gastric cancer vs. chemotherapy alone in MATTERHORN Phase III trial
Positive results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) versus chemotherapy alone. Patients were treated with neoadjuvant IMFINZI in combination with chemotherapy before surgery, followed by adjuvant IMFINZI in combination with chemotherapy, then IMFINZI monotherapy. The trial evaluated this regimen versus perioperative chemotherapy alone for patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
Camizestrant reduced the risk of disease progression or death by 56% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumor mutation in SERENA-6 Phase III trial
Positive results from the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS). The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation.
AstraZeneca’s record seventh year of plenary data at ASCO furthers ambition to redefine breast cancer care and transform outcomes in gastric cancer
AstraZeneca advances its ambition to eliminate cancer as a cause of death with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 to June 3, 2025.
Statistically significant and clinically meaningful BATURA Phase III trial results provide new evidence for AIRSUPRA as standard of care for as-needed rescue treatment in asthma
Positive full results from the BATURA Phase IIIb trial showed AstraZeneca’s anti-inflammatory reliever rescue therapy, AIRSUPRA (albuterol/budesonide), demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to albuterol in patients with mild asthma.1,2 These data were published in the New England Journal of Medicine and presented today at the American Thoracic Society (ATS) 2025 International Conference in San Francisco, CA.1
AstraZeneca to showcase latest research on comprehensive portfolio and pipeline aimed at transforming respiratory diseases at ATS 2025
AstraZeneca will present the latest clinical and real-world data across its leading inhaled, biologic and early science respiratory portfolio at the American Thoracic Society (ATS) International Conference, in San Francisco, CA from May 16 to 21, 2025.
IMFINZI® (durvalumab) regimen demonstrated statistically significant and clinically meaningful improvement in disease-free survival for high-risk non-muscle-invasive bladder cancer in POTOMAC Phase III trial
Positive high-level results from the POTOMAC Phase III trial showed one year of treatment with AstraZeneca’s IMFINZI® (durvalumab) plus standard-of-care BCG induction and maintenance therapy demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) compared to BCG induction and maintenance therapy alone.
ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by THP before surgery showed statistically significant and clinically meaningful improvement in pathologic complete response in high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11
Positive high-level results from the DESTINY-Breast11 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care (dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]) when used in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2-positive early-stage breast cancer. Pathologic complete response is defined as no evidence of invasive cancer cells in the removed breast tissue and lymph nodes following treatment.
BREZTRI met primary endpoints in KALOS and LOGOS Phase III trials in asthma
Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca’s fixed-dose triple-combination therapy BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines.
ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival vs. THP as 1st-line therapy for patients with HER2+ metastatic breast cancer
Positive high-level results from a planned interim analysis of the DESTINY-Breast09 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer.
AZD0780, a novel oral PCSK9 inhibitor, demonstrated significant LDL cholesterol (LDL-C) reduction in PURSUIT Phase IIb trial
Positive results from the PURSUIT Phase IIb trial for AstraZeneca’s AZD0780 demonstrated a statistically significant low-density lipoprotein cholesterol (LDL-C) reduction when administered on top of standard-of-care statin therapy, as compared with placebo.1,2 AZD0780 is an investigational once-daily oral PCSK9 inhibitor for patients currently not reaching their LDL-C lowering goal despite standard-of-care-lipid lowering therapies such as statins.1,2
IMFINZI® (durvalumab) approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer
AstraZeneca’s IMFINZI® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
New study results reinforce TAGRISSO® (osimertinib) as the backbone therapy for EGFR-mutated lung cancer across stages and settings
New study results presented at the European Lung Cancer Congress (ELCC) 2025, March 26 to 29, demonstrate the role of AstraZeneca’s TAGRISSO® (osimertinib), as monotherapy and as the backbone for novel combinations, across stages and settings of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Highlights include:
AstraZeneca and Erin Andrews team up to inspire fans to Get Body Checked Against Cancer
AstraZeneca and Erin Andrews have teamed up as part of a national public health campaign to educate and empower people to Get Body Checked Against Cancer. Erin is a passionate entrepreneur, national sports broadcaster, podcast host, hockey fan and wife — and cancer survivor.
IMFINZI® (durvalumab)-based regimen demonstrated statistically significant and clinically meaningful improvement in event-free survival in resectable early-stage gastric and gastroesophageal junction cancers
Positive high-level results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS). Patients were treated with neoadjuvant IMFINZI in combination with chemotherapy before surgery, followed by adjuvant IMFINZI in combination with chemotherapy, then IMFINZI monotherapy. The trial evaluated this regimen versus perioperative chemotherapy alone for patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
Positive results from the TEZSPIRE Phase III WAYPOINT trial highlight rapid and sustained effect in chronic rhinosinusitis with nasal polyps
Full results from the positive Phase III WAYPOINT trial showed AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for subsequent surgery, and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo.1,2 These data were published in the New England Journal of Medicine and presented today as a late-breaking oral presentation at the American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, CA.1,2
Camizestrant demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival in 1st-line advanced HR-positive breast cancer with an emergent ESR1 tumor mutation in SERENA-6 Phase III trial
Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation.
FINAL DEADLINE ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of AstraZeneca
Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against AstraZeneca PLC (“AstraZeneca” or the “Company”) (
NASDAQ: AZN) and reminds investors of the Feb. 21, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.
AZN Deadline: Rosen Law Firm Encourages AstraZeneca PLC Investors to Secure Counsel Before Important February 21 Deadline in Securities Class Action First Filed by the Firm – AZN
Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of AstraZeneca PLC (
NASDAQ: AZN) between February 23, 2022 and December 17, 2024, both dates inclusive (the “Class Period”), of the February 21, 2025 lead plaintiff deadline in the securities class action first filed by the Firm.
Deadline Soon: AstraZeneca PLC (AZN) Investors Who Lost Money Urged To Contact The Law Offices of Frank R. Cruz About Securities Fraud Lawsuit
The Law Offices of Frank R. Cruz reminds investors of the upcoming February 21, 2025 deadline to participate as a lead plaintiff in the securities fraud class action lawsuit filed on behalf of investors who acquired AstraZeneca PLC (“AstraZeneca” or the “Company”) (
NASDAQ: AZN) securities between February 23, 2022 and December 17, 2024, inclusive (the “Class Period”).
