Metastatic breast cancer

Wave of FDA Fast Track Designations Sparks Renewed Interest in Biotech Sector That's Heating Up

Retrieved on: 
Thursday, December 1, 2022
Aravalli Range, Therapy, Progression-free survival, Neoplasm, Assistant professor, Roche, Breast, OTC, Communication, MUC, Gemcitabine, PDAC, Patient, Hematology, Fast Track, CMBC, KTRA, PD-L1, Bladder cancer, Division, Hoffmann-La Roche, Metastatic breast cancer, FDA, ORR, PD-1, Pancreatic cancer, News, Reindeer, PFS, CRISPR, TSX, National Cancer Institute, Rachel Haurwitz, Ministry, OTCQX, Ministry of Food and Drug Safety, Global Innovation through Science and Technology initiative, ONC, Cancer, Fast track (FDA), Vanderbilt University Medical Center, Pharmaceutical industry, Medical imaging, Agency, Oncolytics Biotech, Food, Atezolizumab

VANCOUVER, British Colombia , Dec. 1, 2022 /PRNewswire/ -- USA News Group  -  A series of new Fast Track designations have been handed out by the United States Food and Drug Administration (FDA) this week, causing a flurry of activity in the markets for the worthy recipients. The most recent to gain such a designation is pelareorep from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) in combination with atezolizumab, an anti-PD-L1 checkpoint inhibitor from Roche Holding AG (OTCQX: RHHBY) for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). Among the small handful of other companies that recently received this distinction for their platforms have been Aravive, Inc. (NASDAQ: ARAV), Caribou Biosciences, Inc. (NASDAQ: CRBU), and Kintara Therapeutics, Inc. (NASDAQ: KTRA).

Key Points: 
  • The Fast Track process is designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need.
  • Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's development plan.
  • Drugs with Fast Track designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.
  • This represents the second FDA Fast Track designation in Oncolytics' history, with the first being for pelareorep in Metastatic Breast Cancer back in May 2017 .

Wave of FDA Fast Track Designations Sparks Renewed Interest in Biotech Sector That's Heating Up

Retrieved on: 
Thursday, December 1, 2022
Aravalli Range, Therapy, Progression-free survival, Neoplasm, Assistant professor, Roche, Breast, OTC, Communication, MUC, Gemcitabine, PDAC, Patient, Hematology, Fast Track, CMBC, KTRA, PD-L1, Bladder cancer, Division, Hoffmann-La Roche, Metastatic breast cancer, FDA, ORR, PD-1, Pancreatic cancer, News, Reindeer, PFS, CRISPR, TSX, National Cancer Institute, Rachel Haurwitz, Ministry, OTCQX, Ministry of Food and Drug Safety, Global Innovation through Science and Technology initiative, ONC, Cancer, Fast track (FDA), Vanderbilt University Medical Center, Pharmaceutical industry, Medical imaging, Agency, Oncolytics Biotech, Food, Atezolizumab

VANCOUVER, British Colombia, Dec. 1, 2022 /PRNewswire/ -- USA News Group  -  A series of new Fast Track designations have been handed out by the United States Food and Drug Administration (FDA) this week, causing a flurry of activity in the markets for the worthy recipients. The most recent to gain such a designation is pelareorep from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) in combination with atezolizumab, an anti-PD-L1 checkpoint inhibitor from Roche Holding AG (OTCQX: RHHBY) for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). Among the small handful of other companies that recently received this distinction for their platforms have been Aravive, Inc. (NASDAQ: ARAV), Caribou Biosciences, Inc. (NASDAQ: CRBU), and Kintara Therapeutics, Inc. (NASDAQ: KTRA).

Key Points: 
  • The Fast Track process is designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need.
  • Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's development plan.
  • Drugs with Fast Track designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.
  • This represents the second FDA Fast Track designation in Oncolytics' history, with the first being for pelareorep in Metastatic Breast Cancer back in May 2017 .

Sermonix Pharmaceuticals Shares Additional Findings From Its ELAINE 1 Clinical Study at the 4th Annual Congress of the International Society of Liquid Biopsy

Retrieved on: 
Friday, October 21, 2022
ESR1, Therapy, PFS, Woman, NASDAQ, Patient, Drug development, Biology, Neoplasm, Aromatase, International Society, Mutation, MAF, CBR, MBC, Liquid biopsy, Menopause, Metastatic breast cancer, Â, Breast cancer, Safety, GLOBE, Fulvestrant, Lasofoxifene, ER, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Poster, Ligand Pharmaceuticals, Duke University, Medical imaging, Pharmaceutical industry, SERM

Investigators evaluated mutant allele fraction (MAF) ctDNA dynamics following treatment with lasofoxifene or fulvestrant.

Key Points: 
  • Investigators evaluated mutant allele fraction (MAF) ctDNA dynamics following treatment with lasofoxifene or fulvestrant.
  • PFS and CBR were 6.04 months and 37% for lasofoxifene versus 4.04 months and 22% for fulvestrant, respectively.
  • Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience in the oncology drug development arena.
  • Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lamberts Pharmaceutical Division.

Susan G. Komen® Advocates to Congress: People with Terminal Breast Cancer Cannot Wait for Federal Help

Retrieved on: 
Thursday, October 13, 2022
Quality of life, Congress, Senate, Democrat, Disease, Amanda, Metastatic breast cancer, Life, Diagnosis, Patient, Metastasis, MBC, Income, Research, Time, House, Social Security Disability Insurance, Social, Medicare, Breast cancer, Breast, Liver, Interview, Susan, Brain, Survival rate, Death, Policy, Health insurance, Birth control, Medical imaging

WASHINGTON, Oct. 13, 2022 /PRNewswire/ -- Hundreds of Susan G. Komen® advocates today told members of Congress they cannot wait any longer to receive federal financial help and health coverage while they're fighting terminal breast cancer. The pending Metastatic Breast Cancer Access to Care Act (H.R.3183/S.1312), which is overwhelmingly supported by Democrats and Republicans in the House and Senate, removes unnecessary and burdensome waiting periods for these benefits.

Key Points: 
  • WASHINGTON, Oct. 13, 2022 /PRNewswire/ -- Hundreds of Susan G. Komen advocates today told members of Congress they cannot wait any longer to receive federal financial help and health coverage while they're fighting terminal breast cancer.
  • Metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast, most often to the lungs, brain, bones and liver.
  • No one should ever be in this situation," said Molly Guthrie, Vice President, Policy and Advocacy at Susan G. Komen.
  • Susan G. Komen is the world's leading nonprofit breast cancer organization, working to save lives and end breast cancer forever.

UHSM Draws Attention to Metastatic Breast Cancer Awareness Day

Retrieved on: 
Thursday, October 13, 2022
Oncology, Health, Consumer, Religion, Managed Care, Pharmaceutical, CDC, Rx, Unite Health Share Ministries, Metastatic breast cancer, Woman, Diagnosis, Bible, Survivor, Education, Hospital, Depression, Man, Cancer, Awareness, App, Learning, Reading, Health, UHSM, Breast cancer, Coventry Health Care, Anxiety, Prescription, Health insurance, Medical imaging

Unite Health Share Ministries (UHSM), a nonprofit, faith-based healthcare sharing ministry supporting Christian believers through member-to-member healthcare sharing memberships, draws attention to Metastatic Breast Cancer Awareness Day, October 13, and hopes its members will join them by sharing support for those with a diagnosis and raising awareness of the importance of early detection.

Key Points: 
  • Unite Health Share Ministries (UHSM), a nonprofit, faith-based healthcare sharing ministry supporting Christian believers through member-to-member healthcare sharing memberships, draws attention to Metastatic Breast Cancer Awareness Day, October 13, and hopes its members will join them by sharing support for those with a diagnosis and raising awareness of the importance of early detection.
  • According to the CDC, 42,000 women and 500 men in the US die from breast cancer each year; among women, breast cancer is the most common cancer and the second leading cause of cancer death.
  • At UHSM, we recognize the toll a cancer diagnosis can have not just on the person, but on the loved ones supporting them, said Christopher Jin, UHSM president.
  • This Metastatic Breast Cancer Awareness Day, UHSM members can take the first step of preemptive care, by scheduling a cancer screening and reading these latest blogs on breast cancer.

All 50 States to Light Iconic Landmarks in Solidarity for Critical Stage 4 Metastatic Breast Cancer (MBC) Research

Retrieved on: 
Monday, October 3, 2022
YouTube, Cancer, Hospital, Metastatic breast cancer, Aloha, Family, Interview, Research, Memory, Disease, Life, Man, Leonard, CEO, Support, List of Facebook features, Mathew Knowles, Death, Hope, Genetic testing, Awareness, Spirituality, Breast, Kilkenny Castle, Jessica, Quality of life, Breast cancer, MBC, Metastasis, Patient, Life expectancy, NEW, GOT, AGT, Founder, Woman, Key Stage 4, Got Talent, Birth control, Entertainment, Pharmaceutical industry, Pfizer

NEW YORK, Oct. 3, 2022 /PRNewswire-PRWeb/ -- METAvivor Research and Support announces the launch of the fourth annual global landmark campaign, #LightUpMBC, to shine a light on the importance of awareness and funding for metastatic breast cancer (MBC) research. Every year, more than 685,000 people worldwide die from metastatic breast cancer (MBC), also known as Stage 4 or advanced breast cancer, for which there is no cure. This happens when the cancer spreads beyond the breast to other parts of the body.

Key Points: 
  • Every year, more than 685,000 people worldwide die from metastatic breast cancer (MBC), also known as Stage 4 or advanced breast cancer, for which there is no cure.
  • While pink has long been synonymous with early-stage breast cancer awareness, pink alone does not resonate with the advanced stage MBC community.
  • METAvivor Research and Support is dedicated to the specific fight of men and women living with Stage 4 metastatic breast cancer.
  • Metastatic Breast Cancer may start in the breast, but its spread to vital organs makes the disease fatal.

Susan G. Komen® and GE Healthcare Partner to Improve Lives and Raise Awareness of Advancements in Diagnostics and Treatment Options for Metastatic Breast Cancer

Retrieved on: 
Wednesday, September 28, 2022
Knowledge, Susan, Thomas Edison, Woman, Metastatic breast cancer, Twitter, NYSE, Mission, MBC, LinkedIn, Senior, News, Partnership, Neoplasm, Patient, Breast cancer, CEO, Goal, Diagnosis, Ecosystem, Death, Research, GE Healthcare, Mortality, Disease, Molecular imaging, Medical imaging, Birth control, Pharmaceutical industry, Facebook

In continuing its support of Susan G. Komen and efforts to improve outcomes for the breast cancer community, GE Healthcare has made a commitment to help Komen provide critical educational programs for the MBC community.

Key Points: 
  • In continuing its support of Susan G. Komen and efforts to improve outcomes for the breast cancer community, GE Healthcare has made a commitment to help Komen provide critical educational programs for the MBC community.
  • "GE Healthcare is delighted to continue working closely with Susan G. Komen in the advancement of breast cancer care solutions.
  • "Being diagnosed with MBC is difficult and there is a lot to learn about the disease and possible treatment options.
  • Susan G. Komen is the world's leading nonprofit breast cancer organization, working to save lives and end breast cancer forever.

Sermonix Pharmaceuticals Shares Details of First-Ever Known Durable Complete Clinical Response in a Metastatic ER+/HER2- Breast Cancer Patient With an ESR1 Mutation After Prior CDK4/6 Inhibitor Treatment Via Single-Agent Hormonally Based Regimen

Retrieved on: 
Wednesday, September 14, 2022
Therapy, Woman, Metastatic breast cancer, Metastasis, CR, Week, Breast cancer, Fulvestrant, European Society for Medical Oncology, Patient, ER, Menopause, Sheba Medical Center, Cure, Duke University, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Oncology, Ligand Pharmaceuticals, Biology, Progression-free survival, Drug development, NASDAQ, Conference, GLOBE, Congress, Ilium, ESR1, Mutation, ESMO, Pharmaceutical industry, Medical imaging, SERM, COLUMBUS

The case report, Durable Complete Remission of Metastatic ER+/HER2- Breast Cancer After Lasofoxifene Therapy, was initially shared Sept. 9 at the ninth-annual Metastatic Breast Cancer Research Conference in Park City, Utah.

Key Points: 
  • The case report, Durable Complete Remission of Metastatic ER+/HER2- Breast Cancer After Lasofoxifene Therapy, was initially shared Sept. 9 at the ninth-annual Metastatic Breast Cancer Research Conference in Park City, Utah.
  • The durable complete response (CR) was reported during Sermonixs Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study.
  • Top-line ELAINE 1 data was presented Sept. 10 during the European Society for Medical Oncology (ESMO) Congress 2022 in Paris.
  • Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lamberts Pharmaceutical Division.

Veru Reports Third Quarter Fiscal 2022 Financial Results; Progresses Sabizabulin Treatment for COVID-19 Towards Regulatory Decisions in Key Territories

Retrieved on: 
Thursday, August 11, 2022
FDA, Death, Woman, Fulvestrant, The New England Journal of Medicine, Everolimus, Risk, Emergency Use Authorization, Trial of the century, Article 18 of the European Convention on Human Rights, GLOBE, FC2, Breast, Standard of care, EUA, Clinical, High Risk, COVID, Sale, Infection, Medicines and Healthcare products Regulatory Agency, Medicine, CDK, Enobosarm, Government, Patient, Review, COVID-19, Company, Lilly, Breast cancer, European Medicines Agency, Expression, Safety, Metastatic breast cancer, Capsule, NASDAQ, U.S. FDA, Â, MHRA, SERM, WHO, Fast Track, Combination, AR, Pharmaceutical industry, Reinsurance, Cryptocurrency, Medical device, Birth control, Verus Pharmaceuticals

--Company Prepares for U.S. and Ex-U.S. Commercial Launches if Emergency Authorizations Are Granted--

Key Points: 
  • By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19.
  • The Company has Completed a Positive Phase 3 COVID-19 Study in Hospitalized Moderate to Severe COVID-19 Patients at High Risk for ARDS.
  • On July 25, 2022, the UKs Medicines and Healthcare Products Regulatory Agency (MHRA) informed the Company that the sabizabulin marketing authorization application will receive expedited review.
  • On July 27, 2022, the European Medicines Agencys Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries.

Athenex Announces Publication of Data from Phase 3 Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients with Metastatic Breast Cancer in the Journal of Clinical Oncology

Retrieved on: 
Monday, July 25, 2022
Nasdaq, Sale, University, IV, GLOBE, Toxicity, Investor relations, Peripheral neuropathy, SEC, History, Research, Compliance, Risk, Therapy, Safety, COVID-19, NASDAQ, Cancer, Cell, Drug development, MD, Survival, Paclitaxel, Manuscript, Infection, NKT, Neutropenia, Metastatic breast cancer, Society, Pharmaceutical industry, Patient

The article, along with results, can be found on the American Society of Clinical Oncology Journals website at this link .

Key Points: 
  • The article, along with results, can be found on the American Society of Clinical Oncology Journals website at this link .
  • We are pleased with the publication of the phase 3 data, which show that oral paclitaxel plus encequidar significantly improves tumor response in patients with metastatic breast cancer, compared to IV administration.
  • With oral administration of paclitaxel plus encequidar, we observed less frequent and less severe neuropathy, which is often a limiting toxicity with IV taxanes.
  • We believe that for appropriate patients with advanced or metastatic breast cancer, this could potentially be an effective at home treatment option.