View Post

Becoming Your Own Best Advocate and Building a Dream Team to Thrive

In In The News by Barbara Jacoby

By: Kristie L. Kahl From: curetoday.com At CURE’s Educated Patient Breast Cancer Summit, Stephanie Seban shared the ways a patient can become their own best advocate to thrive through their breast cancer journey. Patients with breast cancer must be their own best advocates, building their own personal dream team to thrive throughout their journey, Stephanie Seban said in her keynote …

View Post

Potential Immunotherapy Response Markers Emerge in Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Ellie Leick From: onclive.com Data suggest that baseline T-cell clonality and exhaustion markers have significant translational relevance and can serve as prognostic factors of response to pembrolizumab (Keytruda) as maintenance therapy in metastatic breast cancer, explained James M. Reuben, PhD, MBA. In a phase II trial that was presented at the 2019 San Antonio Breast Cancer Symposium, patients with …

View Post

Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (mTNBC)

In Clinical Studies News by Barbara Jacoby

From: yahoo.com In Pivotal Phase 3 KEYNOTE-355 Study, KEYTRUDA Plus Chemotherapy Significantly Improved PFS Compared to Chemotherapy Alone in Patients with mTNBC Whose Tumors Expressed PD-L1 (CPS ≥10) Data to be Presented at an Upcoming Medical Congress and Discussed with Regulatory Authorities Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase …

View Post

Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: Seattle Genetics From: biospace.com – FDA Action Date is August 20, 2020; Application Under FDA’s Real-Time Oncology Review (RTOR) and Orbis Pilot Programs – – Supported by Results from Pivotal HER2CLIMB Trial; First Investigational Therapy in a Pivotal Trial to Include Patients with Metastatic HER2-Positive Breast Cancer with Active Brain Metastases – Seattle Genetics, Inc.. (Nasdaq:SGEN) today announced that …

View Post

FDA Approves Neratinib Combo for HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Gina Columbus From: onclive.com The FDA has approved a supplemental new drug application (sNDA) for neratinib (Nerlynx) in combination with capecitabine (Xeloda) for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.1 The approval is based on findings from the phase III NALA trial, which …

View Post

EMA Validates Seattle Genetics’ Marketing Authorization Application for Tucatinib for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: Seattle Genetics From: pipelinereview.com – Application Supported by Results of Pivotal HER2CLIMB Trial – – First Investigational Therapy in a Pivotal Trial to Include Patients with Metastatic HER2-Positive Breast Cancer with Active Brain Metastases – – EU Marketing Authorization Application (MAA) Follows Recent Submission of Tucatinib New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) – …

View Post

Nanoparticle Therapy Shows Promise with Breast Cancer

In In The News by Barbara Jacoby

By: Deborah Kotz From: umaryland.edu Researchers at the University of Maryland School of Medicine (UMSOM) developed a new nanoparticle drug formulation that targets a specific receptor on cancer cells and appears to be more effective than a standard nanoparticle therapy currently on the market to treat metastatic breast cancer, according to a study published today in the journal Science Advances. The …

View Post

Combination Therapy Improves Progression-Free Survival in Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Jessica Skarzynski From: curetoday.com The combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with Gemzar (gemcitabine) may give some patients with metastatic breast cancer a new life-extending treatment option, even if they’ve seen disease progression after previous therapy, according to research findings from Memorial Sloan Kettering (MSK) Cancer Center in New York City. Previous research showed that combining Perjeta and …

View Post

CDK Inhibitors with Endocrine Therapy Show Survival Benefit in Patients with Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Conor Killmurray From: curetoday.com Adding CDK 4/6 inhibitors to endocrine therapy for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer showed a survival benefit despite patients having differences in their tumors, according to a study published in Lancet Oncology. “To our knowledge, this is the first comprehensive pooled analysis of all marketed CDKIs (CDK 4/6 inhibitors) to …

View Post

Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: Business Wire From: apnews.com Seattle Genetics, Inc. (Nasdaq:SGEN) today announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients …