Orbis

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.

Innovative Education Solutions Leader Norm Allgood Joins Ambow Education to Head HybriU AI Education Technology Business

Retrieved on: 
Wednesday, March 6, 2024

CUPERTINO, Calif., March 6, 2024 /PRNewswire/ -- Ambow Education Holding Ltd. (NYSE American: AMBO) ("Ambow" or the "Company"), an AI technology-driven educational company, today announced the appointment of Norm Allgood as fractional Head of HybriU, effective immediately.

Key Points: 
  • CUPERTINO, Calif., March 6, 2024 /PRNewswire/ -- Ambow Education Holding Ltd. (NYSE American: AMBO) ("Ambow" or the "Company"), an AI technology-driven educational company, today announced the appointment of Norm Allgood as fractional Head of HybriU, effective immediately.
  • In this newly established position, Mr. Allgood will lead the dissemination and implementation of HybriU, Ambow's cutting-edge, AI-driven hybrid learning solution for education and workforce training.
  • Mr. Allgood holds over two decades of experience expanding educational access to quality, programs, launching technology platforms for the education industry, collaborating with higher education partners, strategic planning and operational optimization.
  • This shift requires a right-fit solution, and HybriU remains the only technology specifically designed to address this large untapped market."

Servier Receives Regulatory Filing Acceptances from FDA and EMA for Vorasidenib in the Treatment of IDH-Mutant Diffuse Glioma

Retrieved on: 
Wednesday, February 21, 2024

BOSTON and SURESNES, France, Feb. 21, 2024 /PRNewswire/ -- Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, while the European Commission approval is anticipated in the second half of 2024.

Key Points: 
  • This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma.
  • If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers.
  • "In the realm of glioma treatment, innovation has been stagnant for nearly a quarter-century, posing challenges for patients who, post-surgery, may opt to defer treatment due to concerns around potential toxic side effects.
  • "This promising outcome brings hope to patients grappling with IDH-mutant diffuse gliomas, offering a potential breakthrough for those eagerly awaiting a new therapeutic option."

Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority

Retrieved on: 
Friday, February 2, 2024

This NDA was submitted through Project Orbis, an initiative of the US Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE).

Key Points: 
  • This NDA was submitted through Project Orbis, an initiative of the US Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE).
  • At present, eight regulatory agencies have joined Project Orbis, including the FDA, the Australia Therapeutic Goods Administration (“TGA”), HSA, Health Canada (HC), the U.K.
  • Previously, two NDAs for toripalimab for the treatment of NPC had been submitted to the TGA through Project Orbis and were successfully accepted.
  • Junshi Biosciences will explore accelerated marketing opportunities in countries and regions where it is applicable.

SPIE Announces the Winning Products and Companies at Its 16th Annual Prism Awards

Retrieved on: 
Thursday, February 1, 2024

The gala evening, held during SPIE Photonics West , also marked the Prism Awards’ 16th anniversary.

Key Points: 
  • The gala evening, held during SPIE Photonics West , also marked the Prism Awards’ 16th anniversary.
  • View the full release here: https://www.businesswire.com/news/home/20240201882344/en/
    SPIE announces the winning products and companies at its 16th annual Prism Awards.
  • (Graphic: Business Wire)
    Each year, the SPIE Prism Awards reflect the rapidly growing trajectory of photonics products and photonics-enabled solutions.
  • "We’re always excited to showcase the wealth of innovative optics- and photonics-based technologies during the SPIE Prism Awards," said SPIE CEO Kent Rochford.

XTANDI® (enzalutamide) Receives Health Canada Approval as the First and Only Treatment for High-Risk Patients with Non-Metastatic Castration-Sensitive Prostate Cancer (nmCSPC)

Retrieved on: 
Tuesday, January 30, 2024

MARKHAM, ON, Jan. 30, 2024 /CNW/ - Today, Astellas Pharma Canada, Inc. announced that Health Canada has approved a supplemental New Drug Application for XTANDI® (enzalutamide) in a new prostate cancer treatment setting.

Key Points: 
  • MARKHAM, ON, Jan. 30, 2024 /CNW/ - Today, Astellas Pharma Canada, Inc. announced that Health Canada has approved a supplemental New Drug Application for XTANDI® (enzalutamide) in a new prostate cancer treatment setting.
  • "I welcome the approval of XTANDI as a promising earlier treatment option for eligible patients.
  • This marks a significant step forward in addressing unmet needs for prostate cancer treatment."
  • With our recent acquisition of Propella Therapeutics, Inc., we strive to achieve even more in the investigation of targeted prostate cancer treatments for patients of the future."

ENHERTU® Granted Priority Review in the U.S. for Patients with Metastatic HER2 Positive Solid Tumors

Retrieved on: 
Monday, January 29, 2024

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Key Points: 
  • ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
  • The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in August 2023 for ENHERTU in metastatic HER2 positive solid tumors.
  • Data from other supporting trials in patients with HER2 positive IHC 3+ tumors in the ENHERTU clinical development program, including DESTINY-Lung01 and DESTINY-CRC02 , also were included in the submission.
  • We will continue working closely with the FDA to bring this potential first tumor agnostic HER2 targeted medicine to patients as quickly as possible.”

Orbis International and NIDEK Join Forces to Scale Up Artificial Intelligence Eye Screenings in Vietnam

Retrieved on: 
Tuesday, January 16, 2024

NEW YORK, Jan. 16, 2024 /PRNewswire/ -- Orbis International announces an important in-kind and financial donation from NIDEK to support Orbis's artificial intelligence (AI)-based screening services in Vietnam. The donation of six specialized fundus cameras, which take images of the retina (back of the eye), will support the scale up of Orbis' AI-based diabetic retinopathy screening program in Vietnam. These cameras are expected to support the screening of 72,000 patients with diabetes over the next three years.

Key Points: 
  • NEW YORK, Jan. 16, 2024 /PRNewswire/ -- Orbis International announces an important in-kind and financial donation from NIDEK to support Orbis's artificial intelligence (AI)-based screening services in Vietnam.
  • The donation of six specialized fundus cameras, which take images of the retina (back of the eye), will support the scale up of Orbis' AI-based diabetic retinopathy screening program in Vietnam.
  • These cameras are expected to support the screening of 72,000 patients with diabetes over the next three years.
  • "There are not enough trained medical professionals to meet the demand for eye screening for people living with diabetes.

TomTom Orbis Maps sets new standard for mapmaking with unprecedented coverage and visualization

Retrieved on: 
Tuesday, January 9, 2024

LAS VEGAS, Jan. 09, 2024 (GLOBE NEWSWIRE) -- TomTom (TOM2), the location technology specialist, today announced a milestone in the roll-out of its new TomTom Orbis Maps. The maps now feature unprecedented coverage, including an industry-leading 86 million kilometers of transportation networks. Combining the best of open and proprietary data sources and adding advanced visualization, TomTom's mapmaking platform delivers richer, fresher, and more visually attractive map content.

Key Points: 
  • LAS VEGAS, Jan. 09, 2024 (GLOBE NEWSWIRE) -- TomTom ( TOM2 ), the location technology specialist, today announced a milestone in the roll-out of its new TomTom Orbis Maps.
  • The maps now feature unprecedented coverage, including an industry-leading 86 million kilometers of transportation networks.
  • Drawing on the power of AI and machine learning, TomTom Orbis Maps taps into the richness of OpenStreetMap (OSM), with its millions of active editors.
  • They all recognize the value TomTom Orbis Maps brings through high-quality, reliable maps that are easy to integrate and future-proof.

Junshi Biosciences Announces New Chemical Entity Application for Toripalimab Accepted by Australia’s TGA

Retrieved on: 
Saturday, December 2, 2023

Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of NPC.

Key Points: 
  • Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of NPC.
  • At present, seven other regulatory agencies have joined Project Orbis, including the TGA, Singapore Health Sciences Authority (HSA), Health Canada (HC), MHRA, etc.
  • Toripalimab for the treatment of NPC meets these application requirements and is the first domestic oncology drug to be included in Project Orbis.
  • Junshi Biosciences will explore the possibility of fast marketing in these countries and regions where the pathway is applicable.