Brain metastasis

Data Affirming Biocept's Target Selector™ Platform Identifies Cancer Mutations in Cerebrospinal Fluid Presented at ASCO 2020 Virtual Scientific Program

Friday, May 29, 2020 - 1:30pm

The presence of tumor cells in cerebrospinal fluid may be an indicator of brain metastases, which occur when cancer has spread to the central nervous system.

Key Points: 
  • The presence of tumor cells in cerebrospinal fluid may be an indicator of brain metastases, which occur when cancer has spread to the central nervous system.
  • Biocept's Target Selector assays can detect circulating tumor cells (CTCs) and circulating DNA (ctDNA) and identify cancer associated biomarkers in cerebrospinal fluid.
  • The Company can also identify biomarkers with testing CTCs and ctDNA in the blood of patients diagnosed with cancer.
  • In January 2020, Biocept announced the commercial availability of its Target Selector cerebrospinal fluid assays for the rapid identification of molecular alterations in brain metastases in patients with primary breast or lung cancer.

Seattle Genetics Announces Positive Results from Exploratory Analyses of HER2CLIMB for TUKYSA™ (tucatinib) in Brain Metastases Patients With HER2-Positive Breast Cancer

Friday, May 29, 2020 - 1:00pm

In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 diarrhea and 0.5% with Grade 4 diarrhea.

Key Points: 
  • In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 diarrhea and 0.5% with Grade 4 diarrhea.
  • Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients.
  • Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.
  • TBCRC 022: a phase II trial of neratinib and capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases.

U.S. FDA Approves Takeda’s ALUNBRIG® (brigatinib) as a First-Line Treatment Option for Patients Diagnosed with Rare and Serious Form of Lung Cancer

Friday, May 22, 2020 - 9:30pm

We believe this approval for ALUNBRIG is a substantial step in the right direction and represents significant progress for Takedas broader lung cancer portfolio.

Key Points: 
  • We believe this approval for ALUNBRIG is a substantial step in the right direction and represents significant progress for Takedas broader lung cancer portfolio.
  • Twenty-nine percent of patients had brain metastases at baseline in the ALUNBRIG arm versus 30% in the crizotinib arm.
  • In the ALTA 1L trial, serious adverse reactions occurred in 33% of patients receiving ALUNBRIG.
  • In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), ILD/pneumonitis occurred in 5.1% of patients receiving ALUNBRIG.

Novocure Announces Presentation of EF-19 Post-approval Registry Trial Data Studying Optune as a Monotherapy for the Treatment of Recurrent GBM at the American Association for Cancer Research 2020 Virtual Annual Meeting I

Monday, April 27, 2020 - 12:30pm

Optune as monotherapy reduced the risk of death with fewer adverse events compared to best standard of care chemotherapy.

Key Points: 
  • Optune as monotherapy reduced the risk of death with fewer adverse events compared to best standard of care chemotherapy.
  • The EF-19 data confirm the effectiveness and safety of Optune as monotherapy and further strengthen Optunes clinical profile in recurrent GBM.
  • The virtual meeting will be available free to everyone, although attendees will be asked to register to participate.
  • Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer, liver cancer and gastric cancer.

FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer

Friday, April 17, 2020 - 7:07pm

"The FDA's Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA's international collaborators.

Key Points: 
  • "The FDA's Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA's international collaborators.
  • "This approval represents an additional targeted treatment option for patients with HER2-positive breast cancer.
  • More than 25% of women with metastatic HER2-positive breast cancer will develop brain metastases.
  • Tukysa is approved for treatment after patients have taken one or more anti-HER2-based regimens in the metastatic setting.

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

Thursday, February 13, 2020 - 1:00pm

The FDAs filing of the tucatinib NDA marks an important step forward for patients with locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics.

Key Points: 
  • The FDAs filing of the tucatinib NDA marks an important step forward for patients with locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics.
  • The NDA for tucatinib was submitted in December 2019 and is being reviewed under the Real-Time Oncology Review (RTOR) Pilot Program.
  • The review of the tucatinib NDA is also being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.
  • Tucatinib has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.

Froedtert & the Medical College of Wisconsin Cancer Network Partners with UWM App Brewery for Brain Cancer Patients

Wednesday, January 22, 2020 - 3:46pm

NIMBLE stands for Network for the Integrated Management of Brain Metastasis Linking Experts.

Key Points: 
  • NIMBLE stands for Network for the Integrated Management of Brain Metastasis Linking Experts.
  • It is the brainchild of two experts with the Froedtert & the Medical College of Wisconsin Cancer Network: Joseph Bovi, MD, Medical College of Wisconsin (MCW) associate professor; and Christopher Schultz, MD, FACR, FASTRO, MCW professor and chairman of the Department of Radiation Oncology.
  • Specialists see about 10 times the number of brain metastasis patients versus patients with primary brain cancer (cancer that started in the brain).
  • Creating NIMBLE was central to launching our Brain Metastasis Program and addressing the individual complexity of care for these patients.

Biocept Announces Validation and Availability of its Liquid Biopsy Platform for the Detection of Actionable Cancer Biomarkers in Cerebrospinal Fluid

Tuesday, January 14, 2020 - 1:05pm

Up to 30% and 36% of patients diagnosed with breast and lung cancer, respectively, will develop brain metastases.

Key Points: 
  • Up to 30% and 36% of patients diagnosed with breast and lung cancer, respectively, will develop brain metastases.
  • "Liquid biopsy tests offer the ability to analyze an additional specimen type, beyond blood, to help physicians identify biomarkers and hence inform clinical decision making."
  • The Company uses its proprietary liquid biopsy technology to provide physicians with information for treating and monitoring patients diagnosed with cancer.
  • The Company's patented Target Selector liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both CTCs and in plasma (ctDNA).

Novocure to Participate in the 38th Annual J.P. Morgan Healthcare Conference

Thursday, December 26, 2019 - 12:30pm

Novocure (NASDAQ: NVCR) will participate in the 38th Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2020, in San Francisco.

Key Points: 
  • Novocure (NASDAQ: NVCR) will participate in the 38th Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2020, in San Francisco.
  • He is scheduled to present at 10 a.m. PST in the Elizabethan A/B conference room.
  • Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and liver cancer.
  • Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City.

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

Monday, December 23, 2019 - 1:00pm

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.

Key Points: 
  • 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.
  • Todays submission marks another important milestone for Seattle Genetics and tucatinib, and a potential advance for patients with either locally advanced or metastatic HER2-positive breast cancer, including those with and without brain metastases, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.
  • Tucatinib has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.
  • In addition, investigational agent tucatinib, a small molecule tyrosine kinase inhibitor, is in late-stage development for HER2-positive metastatic breast cancer, and in clinical development for metastatic colorectal cancer.