Cisplatin

Cardiff Oncology Announces Upcoming Presentations at the AACR Annual Meeting 2024

Retrieved on: 
Wednesday, March 6, 2024

“In RAS-mutated mCRC, we are showing the underlying mechanism through which the combination of onvansertib and bevacizumab targets the hypoxia response pathway.

Key Points: 
  • “In RAS-mutated mCRC, we are showing the underlying mechanism through which the combination of onvansertib and bevacizumab targets the hypoxia response pathway.
  • We believe this mechanism explains the strong clinical results we have seen in both our Phase 1b/2 and ONSEMBLE second-line RAS-mutated mCRC clinical trials.
  • The abstracts are available on the AACR Online Program and will be published in the online Proceedings of the AACR.
  • Following presentation, the posters will be posted to the " Scientific Presentations " section of the Cardiff Oncology website.

Fennec Pharmaceuticals Reports Preliminary Unaudited Net Revenue for Fourth Quarter and Full-Year 2023 Results

Retrieved on: 
Thursday, February 29, 2024

RESEARCH TRIANGLE PARK, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced preliminary unaudited fourth quarter and full-year 2023 net revenues.

Key Points: 
  • ~ Company Expects to Report 2023 Fourth Quarter and Audited Full-Year Results on or about March 26, 2024 ~
    RESEARCH TRIANGLE PARK, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced preliminary unaudited fourth quarter and full-year 2023 net revenues.
  • The information in this press release is based upon preliminary unaudited information and management estimates for the fourth quarter 2023 and is subject to the completion of Fennec’s financial closing procedures and year end audit.
  • Preliminary Unaudited 2023 Fourth Quarter Revenue and Year End Performance:
    Fourth quarter 2023 net revenues are expected to be approximately $9.2 to $9.7 million, which represents approximately a 41-49% increase over the third quarter of 2023.
  • Fennec expects to report its 2023 fourth quarter and audited full-year year results of operations on or about March 26, 2024.

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.

Hearing loss company Acousia announces first patient enrolled in its Phase 2 PROHEAR-Study

Retrieved on: 
Thursday, February 15, 2024

TÜBINGEN, Germany, Feb. 15, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study.

Key Points: 
  • TÜBINGEN, Germany, Feb. 15, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study.
  • Germ-cell testicular cancer is the most common cancer among young men, with incidence rates continuously increasing.
  • In preclinical models, ACOU085 has demonstrated its significant potential to reduce cisplatin-induced hearing loss and preserve outer hair cells from ototoxicity.
  • "The enrollment of the first patient into our ACOU085 Clinical Phase 2 program marks a further major milestone in our efforts to finally make acute and subacute forms of hearing loss treatable" said Dr. Tim Bölke, CEO and CMO of Acousia Therapeutics.

Hearing loss company Acousia announces first patient enrolled in its Phase 2 PROHEAR-Study

Retrieved on: 
Thursday, February 15, 2024

TÜBINGEN, Germany, Feb. 15, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study.

Key Points: 
  • TÜBINGEN, Germany, Feb. 15, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study.
  • Germ-cell testicular cancer is the most common cancer among young men, with incidence rates continuously increasing.
  • In preclinical models, ACOU085 has demonstrated its significant potential to reduce cisplatin-induced hearing loss and preserve outer hair cells from ototoxicity.
  • "The enrollment of the first patient into our ACOU085 Clinical Phase 2 program marks a further major milestone in our efforts to finally make acute and subacute forms of hearing loss treatable" said Dr. Tim Bölke, CEO and CMO of Acousia Therapeutics.

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.

FDA Issues Reminder of Non-Substitution of PEDMARK® (sodium thiosulfate injection) for Pediatric Patients Receiving Cisplatin

Retrieved on: 
Thursday, February 1, 2024

PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Key Points: 
  • PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.
  • The FDA reminded health care providers that as stated in PEDMARK’s prescribing information , PEDMARK is not substitutable with other sodium thiosulfate products.
  • Sodium nitrite is co-packaged with sodium thiosulfate as a separate vial in some products; it is not present in PEDMARK.
  • The FDA encourages those with any questions to contact [email protected].

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

Retrieved on: 
Friday, January 12, 2024

Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Key Points: 
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • “Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.
  • The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer.
  • In the exploratory subgroup analysis of 596 patients with FIGO 2014 Stage III-IVA disease, 61 patients (21%) in the KEYTRUDA plus CRT arm (n=293) experienced a PFS event versus 94 patients (31%) in the placebo plus CRT arm (n=303).

Junshi Biosciences Announces Approval of the Supplemental New Drug Application for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients

Retrieved on: 
Tuesday, January 2, 2024

This is the first approved perioperative therapy for lung cancer in China and the second worldwide.

Key Points: 
  • This is the first approved perioperative therapy for lung cancer in China and the second worldwide.
  • In the same year, the number of lung cancer deaths in China amounted to 715,000, accounting for 23.8% of all cancer deaths in China.
  • Amongst these patients, 20%-25% are surgically resectable at first diagnosis, but even after radical surgical treatment, 30%-55% of these patients suffer from post-surgical recurrence and death.
  • One of the first domestic pharmaceutical companies to initiate clinical trials for perioperative immunotherapy, Junshi Biosciences entered the perioperative immunotherapy arena very early on and now holds the broadest spectrum of indications in China.