Cisplatin

Apollomics Announces Approval of Vebreltinib in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene

Retrieved on: 
Donnerstag, April 25, 2024
Glioma, Shanda, MET, WHO, Temozolomide, Safety, Risk, NMPA, National Medical Products Administration, Glioblastoma, Isocitrate dehydrogenase, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Partnership, Trial of the century, Etoposide, OS, History, CNS, IDH, Patient, Neoplasm, Met, APLM, NSCLC, Lung cancer, Pharmaceutical industry

FOSTER CITY, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that its partner in China, Avistone Biotechnology Co. Ltd. (Avistone), received approval from the National Medical Products Administration (NMPA) of China for vebreltinib (APL-101) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments. This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration, and follows the NMPA’s November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).

Key Points: 
  • "The NMPA’s approval of vebreltinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib’s CNS penetration ability and c-Met inhibitory activity in the tumors there," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics.
  • Surgery, radiation treatment, and chemotherapy are current standard treatment strategies for gliomas with poor prognoses.
  • These preliminary data support cross-region similarity of patient response to treatment with vebreltinib.
  • This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.

Junshi Biosciences Announces NDA Acceptance in Hong Kong for Toripalimab

Retrieved on: 
Donnerstag, April 25, 2024
PFS, Shirin David, JAMA, Risk, NDA, Government, Progression-free survival, New Drug Application, American Medical Association, Cisplatin, Death, Immunotherapy, Trial of the century, ASCO, European, Health department, Dor, Patient, Nasopharyngeal carcinoma, Society, NPC, Marketing, Clutch (eggs), Journal, Pharmaceutical industry

Toripalimab plus chemotherapy also reduced the risk of disease progression or death by 48% and the risk of death by 37%, all while demonstrating a manageable safety profile.

Key Points: 
  • Toripalimab plus chemotherapy also reduced the risk of disease progression or death by 48% and the risk of death by 37%, all while demonstrating a manageable safety profile.
  • So far, toripalimab has been approved for marketing in the Chinese mainland and the US.
  • Several NDAs are currently under regulatory review in the European Union, UK, Australia, Singapore, Malaysia and Hong Kong Special Administrative Region (“SAR”).
  • Furthermore, NDAs for toripalimab have also been submitted in India, South Africa, Chile and Jordan.

AIM ImmunoTech Announces Positive Top-Line, Protocol-Planned Interim Report Data from the Study of Ampligen Combined with Pembrolizumab for the Treatment of Recurrent Ovarian Cancer

Retrieved on: 
Mittwoch, April 10, 2024
PFS, University, Epithelium, UPMC Magee-Womens Hospital, Pancreatic cancer, Triple-negative breast cancer, Colorectal cancer, Research, Cisplatin, AIM, MD, Peritoneum, Gynecologic Oncology (journal), UPMC, Gynaecology, Disease, Liver, Patient, CXCL10, CXCL11, Reproductive Sciences, Progression-free survival, Data analysis, Neoplasm, Biomarker, CXCL9, Cancer, RNA, Ovarian cancer, Medical imaging

See further details on the study “Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer” at ClinicalTrials.gov: NCT03734692 .

Key Points: 
  • See further details on the study “Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer” at ClinicalTrials.gov: NCT03734692 .
  • Additionally, the immunological signature supporting this synergistic enhancement has been seen in other clinical trials, including with pancreatic cancer ( 1 , 2 ) metastatic triple-negative breast cancer and colorectal cancer metastatic to the liver .
  • Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and most solid tumors.
  • Additionally, Keynote-100’s median PFS was 2.1 months, or significantly less than that seen in the ongoing Ampligen study.

CHMP Adopts Positive Opinion Recommending Approval of Bristol Myers Squibb’s Opdivo® (nivolumab) in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
Freitag, April 26, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, PFS, Congress, Patient, European Commission, BMY, Priority review, Risk, Food, Progression-free survival, Carcinoma, Neck, Survival, Cisplatin, Death, CHMP, ESMO, Stomach, Hepatocellular carcinoma, Mesothelioma, European, Checkmate, EMA, Committee, Renal cell carcinoma, Melanoma, Head, Bristol Myers Squibb, Confidence interval, European Medicines Agency, Lung cancer, Pharmaceutical industry

The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

Key Points: 
  • The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
  • “New treatment options that may improve responses, delay disease progression, and offer survival benefit in the first-line setting are needed.
  • On March 7, 2024 the U.S. Food and Drug Administration (FDA) approved the use of Opdivo in combination with cisplatin and gemcitabine as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, following a Priority Review.
  • Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -901 clinical trial.

Avistone Announces the Approval of Vebreltinib as the First MET-TKI Treatment for a Rare Brain Glioma Subtype in China

Retrieved on: 
Donnerstag, April 25, 2024
Oncology, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Glioma, Shanda, MET, Temozolomide, Safety, Radiation, NMPA, Glioblastoma, Isocitrate dehydrogenase, Prognosis, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Lung cancer, Etoposide, OS, History, Risk, CNS, Therapy, IDH, Patient, Neoplasm, NSCLC, Pharmaceutical industry

This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration.

Key Points: 
  • This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration.
  • In November 2023, vebreltinib received conditional approval for the treatment of metastatic patients with MET Exon14 Skipping non-small cell lung cancer (NSCLC) from the NMPA.
  • Glioma is a refractory primary malignant intracranial tumor, accounting for approximately 46% of intracranial tumors [1].
  • The approval of vebreltinib for the ZM fusion-positive glioma indications is based on the positive results of the FUGEN study (NCT06105619).

Amneal Launches PEMRYDI RTU®, the First Ready-to-Use Version of Important Oncology Injectable Medicine

Retrieved on: 
Dienstag, April 16, 2024
Biotechnology, Hospitals, Health, Pharmaceutical, Oncology, Radiation, CMS, Pharmacy, Refrigeration, Hospital, Pembrolizumab, Cisplatin, Aplastic anemia, Mesothelioma, Disease, Restrictive lung disease, Pemetrexed, Patient, Medicare, Kidney, ALK, Medication, Amneal Pharmaceuticals, RTU, Pharmaceutical industry

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the launch of PEMRYDI RTU®, the first and only ready-to-use presentation of pemetrexed for injection.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the launch of PEMRYDI RTU®, the first and only ready-to-use presentation of pemetrexed for injection.
  • This product does not require reconstitution, dilution, or refrigeration, which is different than other versions of pemetrexed for injection.
  • “The launch of PEMRYDI RTU highlights Amneal’s deep commitment to oncology as we invest to develop injectable products that are important to healthcare providers and patients,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology.
  • PEMRYDI RTU® injectable is available in two vial sizes: 100mg/10mL and 500 mg/50mL.

Excellent Cancer Care, Exclusive Clinical Trials

Retrieved on: 
Dienstag, April 23, 2024
Cancer, Hope, Triple-negative breast cancer, Survival, Cisplatin, MD, Research, Prostate cancer, Lymphoma, Patient, Society, Multimedia, Melanoma, Clinical trial, Quality of life, Medical imaging

KNOXVILLE, Tenn., April 23, 2024 /PRNewswire/ -- Every treatment prescribed by a doctor today was once a part of research in a clinical trial. Clinical research is thriving at Thompson Cancer Survival Center.

Key Points: 
  • Clinical research is thriving at Thompson Cancer Survival Center .
  • Thirty years after its beginning, Thompson remains a leader in pivotal clinical research .
  • Dr. Chism and the clinical research team continue to spearhead oncology trials for patients in East Tennessee.
  • Clinical trials offer new options for cancer patients now and new hope for cancer patients in the future.

HUTCHMED Highlights Data to be Presented at AACR Congress 2024

Retrieved on: 
Freitag, April 5, 2024
IOV, Tao, Medicine, Savolitinib, VEGFR, Immunotherapy, Patient, MMAE, ERK, Relapse, Neoplasm, University, Huachung University, Cisplatin, Lymphoid leukemia, Lymphoma, Chongqing Medical University, Cholangiocarcinoma, Tyrosine-protein kinase SYK, Classification, Efficacy, MET, ADC, Cardiotoxicity, Nanjing Medical University, Non-receptor tyrosine kinase, Safety, Ferroptosis, Macrophage, Pancreatic cancer, Dual role, National Taiwan University Hospital, GPR34, Oncology, Guangzhou Medical University, MD Anderson Cancer Center, Daratumumab, HCM, NPM1, MLL, 301 Hospital, Acute leukemia, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.
  • Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of certain types of acute leukemia.
  • Compared with five other menin inhibitors in clinical development, HMPL-506 showed the stronger inhibitory potency in MLL-rearranged and NPM1 mutant leukemia cell line models.
  • Furthermore, HMPL-506 in combination with azacytidine, venetoclax or gilteritinib synergistically improved the anti-tumor effect against MLL-rearranged leukemias both in vitro and in vivo.

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

Retrieved on: 
Freitag, März 29, 2024
CPS, Patient, Lung cancer, IND, Infection, Cancer, Investment, Cisplatin, Paclitaxel, Melanoma, Marketing, RNA, New chemical entity, Gentlemen's agreement, NRDL, Food, Therapeutic Goods Administration, Biologics license application, Insurance, Research, Junshi, National Medical Products Administration, TGA, FDA, NMPA, Tablet, COVID-19, NPC, Spacecraft, DSM-IV codes, Dacarbazine, Axitinib, Total, Pharmaceutical industry

SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.

Key Points: 
  • SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.
  • Total research and development (“R&D”) expenses were approximately RMB1,937 million in 2023, representing a decrease of approximately 19% compared to 2022.
  • Loss attributable to owners was RMB2,282 million in 2023, representing a decrease of RMB104 million compared to the previous year.
  • This application was later approved for marketing in December 2023, marking the first and only approved perioperative therapy for lung cancer domestically.

Galera Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Donnerstag, März 28, 2024
Research, HNC, Symantec Endpoint Protection, Head, Type, Manganese, Chronic kidney disease, Incidence, ASN, CKD, New Drug Application, LAPC, Patient, Layoff, CRL, NDA, Cancer, Galera, Workforce, Pancreatic cancer, Clinical trial, Cisplatin, Society, Therapy, GRECO, File, Food, SOM, FDA, PDUFA, Pharmaceutical industry

We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.

Key Points: 
  • We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.
  • The Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA was August 9, 2023.
  • Research and development expenses were $3.2 million in the fourth quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $2.0 million in the fourth quarter of 2023, compared to $5.0 million for the same period in 2022.