BRCA

U.S. Food and Drug Administration (FDA) Approves FoundationOne®CDx as a Companion Diagnostic for Janssen’s AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Monday, August 14, 2023
Biotechnology, Pharmaceutical, Men, Oncology, Health, FDA, Genetics, Consumer, Prostate cancer, NGS, Cancer, Janssen, ZERO, Doctor of Philosophy, MD, Patient, BRCA, Foundation Medicine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Education, Food, Medical imaging

Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor.

Key Points: 
  • Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor.
  • The test currently has over 30 companion diagnostic indications.
  • The company also has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing.
  • “This companion diagnostic specifically will help enable broader access to an important new therapy option in BRCA1/2+ mCRPC.

DNA Repair Discoveries Hold Promise for New Approaches to Cancer Treatment

Retrieved on: 
Wednesday, August 16, 2023
Memorial Sloan Kettering Cancer Center, DNA, Radiation, WCM, Nature, DNA repair, NYU Langone Health, BRCA1, Microscopy, Cancer, MSKCC, Breast, Mutation, Cell, Doctor of Philosophy, Whole genome sequencing, National Cancer Institute, Protein, Chromosome, MD, Patient, WGS, Weill Cornell Medicine, Biology, Anurag Agrawal (medical scientist), BRCA2, BRCA, NCI, Homologous recombination, Vaccine, Microscope

In cells that cannot repair DNA effectively, changes (mutations) can occur that lead to cancer.

Key Points: 
  • In cells that cannot repair DNA effectively, changes (mutations) can occur that lead to cancer.
  • Most cells rely on a system called homologous recombination or HR, which uses proteins called BRCA1 and BRCA2 for accurate DNA repair.
  • For this reason, identifying patients with "HR-deficient" cancers has become a priority in the field, in part because such cancer cells are vulnerable to targeted therapies that break their DNA.
  • This work was supported by the Starr Cancer Consortium Award I11-005, National Cancer Institute (NCI) 1P50CA247749, and the Burroughs Wellcome Fund Career Award for Medical Scientists.

U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Friday, August 11, 2023
DSM-IV codes, Janssen Pharmaceuticals, Neoplasm, AE, Prostate cancer, Abiraterone acetate, CI, Drug, Constipation, BC Cancer Agency, Janssen, Prognosis, Mutation, AAP, RPF, CHES, ZERO, Science, Hypertension, Prednisone, Death, TCC, Patient, Hazard, TSP, Medicine, Cancer, HR, Genetic testing, Nausea, IA2, Johnson & Johnson, BRCA, FDA, PARP, Education, Disease, Safety, Fatigue, Pharmaceutical industry, Medical imaging, HORSHAM

HORSHAM, Pa., Aug. 11, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food & Drug Administration (FDA) has approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test.1

Key Points: 
  • *, Medical Oncologist at BC Cancer – Vancouver and principal investigator of the Phase 3 MAGNITUDE study.
  • "All individuals diagnosed with prostate cancer should consider genetic testing, especially those from racial and ethnic minority groups who tend to have worse cancer outcomes.
  • This is imperative to close the racial and ethnic disparities in prostate cancer health outcomes."
  • "This milestone, which marks the approval of Janssen's third prostate cancer treatment, highlights the importance of advancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive mCRPC."

The Gray Foundation Announces $25 Million in New Funding for BRCA-Related Cancer Research

Retrieved on: 
Thursday, August 10, 2023
Biotechnology, Health, Science, Research, Oncology, Yale School of Medicine, Science of team science, Cleveland Clinic, University, Duke Cancer Institute, Grey, Doctor of Philosophy, Penn, Memorial Sloan Kettering Cancer Center, Cancer, Weill Cornell Medicine, BRCA, Johns Hopkins School of Medicine, Cleveland, University of Texas System, Pharmaceutical industry, Management, MD

The Gray Foundation today announced $25 million in funding for 7 research teams to study new approaches for prevention, early detection, and interception of BRCA-related cancers.

Key Points: 
  • The Gray Foundation today announced $25 million in funding for 7 research teams to study new approaches for prevention, early detection, and interception of BRCA-related cancers.
  • The new grants are part of the Foundation’s ongoing Team Science program, which funds innovative BRCA-related collaborative research.
  • The selected multi-institutional, multi-disciplinary teams will commence studies into a variety of topics related to prevention, early detection, and interception.
  • We are inspired to support this cutting-edge research across institutions as we continue to make progress in early detection, prevention, and interception of BRCA-related cancers.”
    With these grants, the Gray Foundation has committed $187 million to supporting BRCA research.

Health in Her HUE to Host Discussion Around Fibroids Awareness and Launch the Fibroids-focused Care Squad Program during Fibroid Awareness Month

Retrieved on: 
Monday, June 26, 2023
Survivor, Endometriosis, Partnership, Boston University Chobanian & Avedisian School of Medicine, Obstetrics, Education, Boston Medical Center, Health equity, Woman, Human, Black, SMPA, Boston University School of Public Health, Patient, SAN, Roivant Sciences, Uterine fibroid, Disease, Gynaecology, Mortality, BRCA, Fibroid, MPH, Breast cancer, Therapy, Empowerment, Nursing, Health

NEW YORK and SAN MATEO, Calif., June 26, 2023 /PRNewswire/ -- Today, Health in Her HUE ("HIHH"), a company dedicated to connecting Black women and women of color to culturally competent and sensitive healthcare providers, announced an ongoing collaboration with Myovant Sciences Ltd. ("Myovant"), soon to be Sumitomo Pharma America, Inc. ("SMPA") as a result of the combination announced April 2023. The collaboration will kick-off with a fireside chat titled "Fighting Fibroids Together: A Candid Conversation Over Brunch," in New Orleans, Louisiana on July 1st, 2023 during the ESSENCE festival weekend. In acknowledgement of Fibroid Awareness Month, this event aims to support education and awareness efforts for historically underserved populations diagnosed with uterine fibroids.

Key Points: 
  • The collaboration will kick-off with a fireside chat titled "Fighting Fibroids Together: A Candid Conversation Over Brunch," in New Orleans, Louisiana on July 1st, 2023 during the ESSENCE festival weekend.
  • In acknowledgement of Fibroid Awareness Month, this event aims to support education and awareness efforts for historically underserved populations diagnosed with uterine fibroids.
  • The event will help launch HIHH's new Fibroids-focused Care Squad , which focuses on guiding participants toward a better understanding of fibroids as a health relevant condition and the possible linkage between fibroids and other health diagnoses.
  • With a wealth of experience in fibroids, endometriosis, and disparities in maternal morbidity and mortality, Dr. Noel is a leading voice in women's health and developed the content for the Fibroids-focused Care Squad.

FDA Approves LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Retrieved on: 
Thursday, June 1, 2023
Biotechnology, General Health, FDA, Health, Pharmaceutical, MSD, Prednisolone, Disease, Ars, Diarrhea, NHA, NR, Duke Cancer Institute, The New England Journal of Medicine, OS, Cancer, MRK, RPF, AstraZeneca, Abdominal pain, NEJM, Merck & Co., Prednisone, Dizziness, SCM, Lymphocytopenia, Patient, Anemia, European, Nausea, BRCA, ITT, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, AR, Food, Caregiver, Fatigue, Prostate cancer, Pharmaceutical industry, Medical imaging, EU, MD, Propel, Merck

As previously reported, there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial (n=796).

Key Points: 
  • As previously reported, there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial (n=796).
  • Approximately 10% of patients with mCRPC will have BRCA mutations, which are associated with a poor prognosis and worse outcomes.
  • LYNPARZA plus abi/pred is approved in several other countries for the treatment of appropriate adult patients with mCRPC based on the PROpel trial.
  • For the U.S. indication, patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

ASCO 2023: Integra Connect to Showcase how its Technology and Real-World Data are Helping Deliver on the Promise of Value-based, Precision Oncology

Retrieved on: 
Friday, May 26, 2023
EOL, Abstract, Oncology Care Model, Maintenance, OCM, Marie Cassidy, Survival, Water Quality Initiative, Cancer, Lung cancer, Thermo Fisher Scientific, NSCLC, Immunotherapy, Quality, ASCO, Organization, BD, Community, Health care, American Society of Clinical Oncology, MD, Patient, Machine learning, Medicine, Annual general meeting, UPMC, ICU, BRCA, Poster, ED, Ovarian cancer, Death, Health, Society, III, Prostate cancer, SACT, Pharmaceutical industry, Medical device, Medical imaging, Nursing, Research

WEST PALM BEACH, Fla., May 26, 2023 /PRNewswire/ -- Integra Connect, LLC., the leading provider of value-based, precision medicine solutions and services for specialty care, today announced that results from 12 studies will be highlighted during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6. The studies, conducted by Integra Connect and leading organizations such as Thermo Fisher Scientific, will highlight how:

Key Points: 
  • Leading provider organizations and Integra Connect evaluated data from oncology value-based care programs and uncovered trends on to how to best support oncology patients, from bedside care to treatment.
  • Integra Connect's robust real-world, de-identified oncology data set was utilized by leading life sciences organizations for five studies that were accepted as online abstracts by ASCO.
  • This research shows broad implications for the use of de-identified real-world data to identify treatment gaps and improve patient care.
  • Results from those studies will be available via online abstract:
    For more insights on Integra Connect's research and presence at ASCO 2023, please go here .

Gilead Strengthens Early Pipeline in Oncology and Inflammation Through the Acquisition of XinThera

Retrieved on: 
Tuesday, May 9, 2023
Biotechnology, Hospitals, Health, Pharmaceutical, Oncology, DNA, Gilead Sciences, IPR, HRD, Neoplasm, Cancer, Breast, MK2, Inflammation, Prostate, PARP1, Acquisition, Patient, Science, Financial toxicity, EPS, BRCA, Sacituzumab govitecan, Pharmaceutical industry, Research

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the acquisition of all outstanding shares of XinThera, a privately held biotech company in San Diego.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced the acquisition of all outstanding shares of XinThera, a privately held biotech company in San Diego.
  • The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation.
  • Through the acquisition, Gilead gains rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology and MK2 for inflammatory diseases that could enter clinical trials later this year.
  • We expect the transaction with XinThera to reduce Gilead’s GAAP and non-GAAP 2023 EPS by approximately $0.12 - $0.15.

 Business Leaders Come Together in Support of The Larry Fitzgerald Foundation’s Largest Annual Fundraiser

Retrieved on: 
Tuesday, May 9, 2023
Retail, Health, Entertainment, Consumer, Restaurant, Bar, Celebrity, Philanthropy, Oncology, Primary, Secondary, Education, Fund Raising, Other Consumer, Foundation, Food, Beverage, Diamond, Morgan Stanley, Bell Bank, Human, Bell, VIP, Partnership, Travel, 2008 Arizona Cardinals season, Friends, Arizona Cardinals, GMI, Fiesta Bowl, AXON, Multimedia, Denver 2008 Convention Host Committee, NBC, Supper club, Fitz, Mentalism, Investment, Breast cancer, Gold, 1991 Fiesta Bowl, Ryan Companies, Thunderbird, Steakhouse, BRCA, Snell & Wilmer, Bank, Snell, Nightclub, FitzGerald, American Express

View the full release here: https://www.businesswire.com/news/home/20230509005676/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230509005676/en/
    Founder Larry Fitzgerald Jr. and Executive Director Danielle Frost of The Larry Fitzgerald Foundation at Fitz's Supper Club hosted by Dominick’s Steakhouse in Scottsdale on May 8, 2023.
  • Each year, the event brings together generous business and community leaders who share a passion for improving K-12 education and supporting the fight against breast cancer.
  • “The investments enable The Larry Fitzgerald Foundation to drive our mission forward and create meaningful impact in our communities.
  • “Larry Fitzgerald gives where it’s needed most in the community,” said Jeff Mastro, CEO and Co-Founder of Dominick’s Steakhouse.

Genome Insight Launches in the U.S. with Innovative Whole Genome Sequencing Approach that Offers Unprecedented, Actionable Insights in Cancer Care

Retrieved on: 
Monday, May 8, 2023
Genomics, Breast, Cancer, Research, Patient, Physician, SAN, Medicine, WGS, Diagnosis, Neoplasm, BRCA, Insight, American Association for Cancer Research, Genome, Medical imaging, Vaccine

SAN DIEGO, May 8, 2023 /PRNewswire/ -- Genome Insight, a leading precision medicine and genomics company, announced today the U.S. launch of CancerVision, their innovative whole genome sequencing (WGS) test designed to provide accurate, timely and medically meaningful insights that collectively guide personalized healthcare decisions. The company also announced the opening of their corporate headquarters located in San Diego, California.

Key Points: 
  • "Up to this point, WGS has not been a viable option for cancer diagnosis because the data are too big, complex and expensive.
  • Genome Insight's model enables a more unbiased genome sequencing not reliant on specific panels that also democratizes access broadly to community physicians everywhere.
  • "Our goal is to sequence genomic data for one million cancer patients, progressing our understanding of cancer for improved patient outcomes."
  • Following CancerVision, Genome Insight intends to expand testing to genomic based therapeutic areas beyond cancer, including rare disease.