Hematology

Bristol Myers Squibb to Participate in Upcoming Investor Conferences

Retrieved on: 
Wednesday, March 6, 2024

Bristol Myers Squibb (NYSE: BMY) today announced that the company will participate in two upcoming investor conferences in March 2024.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the company will participate in two upcoming investor conferences in March 2024.
  • Samit Hirawat, M.D., executive vice president, chief medical officer, Drug Development, will take part in a fireside chat at the Leerink Partners Global Biopharma Conference 2024 in Miami Beach, Florida, on Wednesday, March 13, 2024.
  • He will answer questions about the company beginning at 10:00 a.m.
  • Investors and the general public are invited to listen to both sessions at their respective times by visiting http://investor.bms.com .

Children’s Hospital Los Angeles Awarded $6 Million from CIRM to Advance CAR T-Cell Therapies in Recurring Solid Tumors in Children

Retrieved on: 
Friday, March 1, 2024

Children’s Hospital Los Angeles has received a multi-year $6 million award from the California Institute for Regenerative Medicine (CIRM) to develop innovative stem cell approaches to treat children and adolescents with recurrent solid tumors.

Key Points: 
  • Children’s Hospital Los Angeles has received a multi-year $6 million award from the California Institute for Regenerative Medicine (CIRM) to develop innovative stem cell approaches to treat children and adolescents with recurrent solid tumors.
  • (Photo: Business Wire)
    When cancer reoccurs in children and young adults with solid tumors such as sarcomas and neuroblastomas, there are few good treatment options.
  • This is why Children’s Hospital Los Angeles researchers focus on finding novel therapies using the patient’s own immune cells to treat childhood cancers.
  • In 2022, CIRM awarded $8 million to the Keck School of Medicine of USC and Children’s Hospital Los Angeles to establish a CIRM Alpha Clinic.

BeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia

Retrieved on: 
Thursday, February 29, 2024

The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival.

Key Points: 
  • The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival.
  • These data will be presented during the 28th Annual International Congress on Hematologic Malignancies® in Miami from February 29 - March 3.
  • “Head-to-head randomized clinical trials are the gold standard when it comes to evaluating the potential impact of individual treatments for patients.
  • The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.

PharmaEssentia’s BESREMi (ropeginterferon alfa-2b-njft) Now Recommended as a Preferred First-line Cytoreductive Therapy for Polycythemia Vera in Updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)

Retrieved on: 
Tuesday, February 27, 2024

National Comprehensive Cancer Network® (NCCN®) is a well-recognized, not-for-profit alliance of leading cancer centers in the United States.

Key Points: 
  • National Comprehensive Cancer Network® (NCCN®) is a well-recognized, not-for-profit alliance of leading cancer centers in the United States.
  • The updated NCCN Guidelines® were released on December 21, 2023.
  • “This is another important milestone for BESREMi as a preferred, FDA-approved option for both symptomatic low- and high-risk PV patients,” said Albert Qin, M.D., Ph.D., Chief Medical Officer at PharmaEssentia Corporation.
  • “We are encouraged by the increasing dialogue across academic and community healthcare practitioners rethinking treatment approaches given the potential of BESREMi for this myeloproliferative neoplasm.”

KaliVir Immunotherapeutics Appoints James M. Burke, M.D., as Chief Medical Officer

Retrieved on: 
Wednesday, February 21, 2024

KaliVir Immunotherapeutics, Inc. , a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announced the appointment of industry leader James M. Burke, M.D., as Chief Medical Officer (CMO) to further advance its vision of providing patients with truly life changing cancer therapeutics by leveraging its next generation oncolytic virus platform.

Key Points: 
  • KaliVir Immunotherapeutics, Inc. , a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announced the appointment of industry leader James M. Burke, M.D., as Chief Medical Officer (CMO) to further advance its vision of providing patients with truly life changing cancer therapeutics by leveraging its next generation oncolytic virus platform.
  • Dr. Burke brings over 20 years of global development experience in immuno-oncology.
  • “We are thrilled to welcome Dr. Burke to our team as we bring our pipeline of multi-mechanistic oncolytic virus programs into the clinic,” said Helena Chaye, Ph.D., J.D., Chief Executive Officer of KaliVir.
  • Previously, Dr. Burke was Chief Medical Office at Sillajen, Jennerex and Turnstone Biologics.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
Thursday, March 7, 2024

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1
    In the trial, with a median follow-up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171).1,4 Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone (HR 0.72; 95% CI: 0.59, 0.88; p=0.0012).1
    Additionally, in exploratory analyses, treatment with Opdivo in combination with cisplatin and gemcitabine resulted in an objective response rate (ORR) of 57.6% (n=175) (95% CI: 51.8, 63.2) versus 43.1% (n=131) (95% CI: 37.5, 48.9) with cisplatin-gemcitabine alone.1,4 The complete response (CR) rate and partial response (PR) rate seen in patients treated with Opdivo in combination with cisplatin and gemcitabine was 22% (n=66) and 36% (n=109), respectively, versus 12% (n=36) and 31% (n=95) with cisplatin-gemcitabine alone.1
    “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients a chance to live longer,”5 said Guru P. Sonpavde, MD, Medical Director of Genitourinary Oncology and the Phase I Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, Orlando, Florida.
  • “Based on outcomes and the safety profile seen in the CheckMate -901 clinical trial, the approval of Opdivo in combination with cisplatin and gemcitabine has the potential to change how metastatic or unresectable UC is treated for certain patients and offers them new hope.”1
    Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.
  • Please see Important Safety Information below.1
    “Bringing Opdivo to the first-line setting in UC with chemotherapy is the latest realization of our history of research and progress in immunotherapy, which has helped transform the treatment landscape for many cancers, including bladder cancer,”1,6 said Wendy Short Bartie, senior vice president and general manager, U.S. Hematology and Oncology at Bristol Myers Squibb.
  • “This milestone adds a meaningful expansion to our portfolio of Opdivo-based treatments in genitourinary cancers, where we now have offerings in UC spanning three indications across stages of disease and treatment needs.”1
    The FDA previously approved Opdivo for the adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC; it also previously approved Opdivo for the treatment of adult patients with locally advanced or metastatic UC who have had disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.1
    Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) leading to today’s approval was granted Priority Review status by the FDA, and was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.7 The review was also conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries where the application remains under review.

Global Times: How two sessions serve as bridge between people and government, help authorities formulate policies

Retrieved on: 
Friday, March 8, 2024

Various localities in the country are implementing policies on medication, health insurance and research according to the catalog.

Key Points: 
  • Various localities in the country are implementing policies on medication, health insurance and research according to the catalog.
  • In 2021, China also for the first time included a rare disease treatment in its National Reimbursement Drug List.
  • These moves together benefited thousands of Chinese suffering from rare diseases, including spinal muscular atrophy (SMA) patient Zhang Jianuo and his parents.
  • Motions and proposals during the two sessions are crucial pathways for addressing issues impacting people's livelihood, and they're becoming increasingly effective.

Florida Cancer Specialists & Research Institute Implements Contingency Plan to Overcome National Clearinghouse Outage

Retrieved on: 
Thursday, March 7, 2024

FORT MYERS, Fla., March 7, 2024 /PRNewswire/ -- In the wake of the cyberattack and subsequent outage of Change Healthcare, Florida Cancer Specialists & Research Institute, LLC (FCS) stands resolute in its commitment to patient care and safety. Change Healthcare, the nation's largest clearinghouse for prescriptions, shut down its prescription processing system impacting over 900,000 physicians, 67,000 pharmacies, and 5,500 hospitals in the United States, including FCS and its medically integrated pharmacy, Rx To Go, LLC. Despite the challenges imposed by Change Healthcare's outage, the FCS and Rx To Go dedicated teams remained steadfast in delivering the highest standard of care to patients.

Key Points: 
  • FORT MYERS, Fla., March 7, 2024 /PRNewswire/ -- In the wake of the cyberattack and subsequent outage of Change Healthcare, Florida Cancer Specialists & Research Institute, LLC (FCS) stands resolute in its commitment to patient care and safety.
  • Florida Cancer Specialists & Research Institute and Rx To Go respond to Change Healthcare cyberattack and shutdown.
  • As FCS learned of the shutdown, a comprehensive contingency plan was put in place to ensure that patient care continues with minimal disruption.
  • To overcome the lasting effects from this attack on the medical community, it will require industry-wide collaborative efforts and interventions.

The Inner Circle acknowledges Amir A. Rasheed as a Distinguished Healthcare Professional

Retrieved on: 
Thursday, March 7, 2024

SUGARLAND, Texas, March 7, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Amir A. Rasheed is acknowledged as a Distinguished Healthcare Professional for his contributions to the fields of Oncology and Hematology.

Key Points: 
  • SUGARLAND, Texas, March 7, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Amir A. Rasheed is acknowledged as a Distinguished Healthcare Professional for his contributions to the fields of Oncology and Hematology.
  • Dr. Rasheed pursued his medical education at Dow Medical College where he earned a medical degree.
  • He then relocated to the United States to complete a residency in internal medicine at the State University of New York Health Science Center at Brooklyn.
  • Known for his compassionate care and clinical excellence, Dr. Rasheed has dedicated his life to delivering the highest standard of quality care to his patients.

Caris Life Sciences Partners with Beat Childhood Cancer Research Consortium at Penn State University to Improve Outcomes for Pediatric Patients

Retrieved on: 
Tuesday, March 5, 2024

IRVING, Texas, March 5, 2024 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, today announced an ongoing collaboration with the Beat Childhood Cancer Research Consortium, a group of over 50 universities and children's hospitals, based at Penn State College of Medicine in Hershey, Pa., that offers a worldwide network of pediatric cancer clinical trials.

Key Points: 
  • Caris is now the molecular analysis partner for Beat Childhood Cancer Research Consortium studies.
  • As part of the collaboration to advance precision oncology and biomarker-driven research, Caris is now the molecular analysis partner for Beat Childhood Cancer Research Consortium studies.
  • In addition to tumor sequencing for new or recurring pediatric cancer patients, Caris and the Beat Childhood Cancer Research Consortium will also collaborate on research opportunities striving to advance pediatric patient care and improve outcomes.
  • "The Beat Childhood Cancer Research Consortium is excited to collaborate with Caris to expand our precision medicine program.