Pemetrexed

BeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

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星期二, 四月 23, 2024
Biotechnology, Pharmaceutical, Health, Oncology, PFS, Patient, Paclitaxel, Hospital, Food, European Commission, Neutropenia, JAMA Oncology, Survival, BGNE, Tislelizumab, Docetaxel, ESCC, European, Disease, Journal, Pemetrexed, Leukopenia, Neoplasm, Civil service commission, Carboplatin, ALK, EGFR, NSCLC, European Medicines Agency, Overalls, Lung cancer, Pharmaceutical industry

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.
  • “Today’s EC authorization marks the second in the region for tislelizumab, with both NSCLC and locally advanced or metastatic esophageal squamous cell carcinoma now approved in the European Union.
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.

Lantern Pharma Receives Regulatory Approval to Expand Harmonic™ Clinical Trial for Non-Small Cell Lung Cancer in Never-Smokers into Japan and Taiwan

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星期一, 四月 22, 2024
Technology, Clinical Trials, Health Technology, Software, Biotechnology, Pharmaceutical, Health, Data Management, Oncology, Artificial Intelligence, Education, National Cancer Center, MET, D.C, Lung cancer, Woman, PMID, Progression-free survival, Harmonic, Machine learning, AME Publishing Company, ClinicalTrials.gov, Collection, Artificial intelligence, IPhone, Adenocarcinoma, ROS1, Disease, Incidence, Patient, Pemetrexed, TMB, SOC, Neoplasm, Lung, ALK, EGFR, NSCLC, Carboplatin, Overalls, Gene, TK, Pharmaceutical industry

Approximately one third of all lung cancer patients in East Asia are never-smokers and the proportion of lung cancer in never smokers (LCINS) has been increasing gradually over time, according to a publication in Translational Lung Cancer Research (1).

Key Points: 
  • Approximately one third of all lung cancer patients in East Asia are never-smokers and the proportion of lung cancer in never smokers (LCINS) has been increasing gradually over time, according to a publication in Translational Lung Cancer Research (1).
  • LCINS are histologically, mutationally, and epidemiologically distinct from smoking-related lung cancers and occur almost exclusively as adenocarcinomas and most commonly in women and individuals of Asian ancestry.
  • Dr. Goto will now lead the trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States.
  • In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated.

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

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星期二, 四月 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.

Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer

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星期四, 三月 21, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, OS, Pemetrexed, Chemotherapy, NSCLC, Progression-free survival, Patient, Carboplatin, Merck & Co., MRK, PARP, Cisplatin, PFS, Pharmaceutical industry

In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).

Key Points: 
  • In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).
  • The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies.
  • “These results are an important reminder of how challenging it may be to treat these patients with metastatic nonsquamous non-small cell lung cancer.
  • We sincerely thank the patients and investigators for their important contributions to this study.”

BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

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星期一, 二月 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Carboplatin, European Commission, EMA, JAMA Oncology, EGFR, Committee, Tislelizumab, MAA, Neoplasm, FDA, Quality of life, Cancer, Food, ESCC, Pemetrexed, BGNE, European, Lung cancer, Civil service commission, CHMP, European Medicines Agency, Paclitaxel, Patient, Journal, Survival, ALK, Pharmaceutical industry

As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.

Key Points: 
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
  • Tislelizumab is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
  • BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab with over 13,000 patients enrolled to-date, of which 15 have already reported positive readouts.

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer

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星期一, 二月 19, 2024
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, Metabolism, Immunotherapy, AstraZeneca, News, Daiichi Sankyo, National Cancer Institute, Lung cancer, Triple-negative breast cancer, Immunology, Patient, Cleavage, Biopharmaceutical, Social media, Progression-free survival, Treatment, BLA, Docetaxel, IHC, DXD, Pharmacotherapy, NSCLC, Breast cancer, Gefitinib, PD-1, Safety, Lung, Pemetrexed, PFS, American Cancer Society, Pircher, Observational study, MD, Sapporo Medical University, Food, Cancer, ADC, OS, Immunoglobulin G, Death, Medicine, Pharmaceutical industry

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.

Key Points: 
  • AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.
  • In patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful PFS benefit and a numerically favorable OS trend.
  • Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

TAGRISSO® (osimertinib) demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial

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星期一, 二月 19, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, NSCLC, Fever, Progression-free survival, PFS, AstraZeneca, Heart, Periodic breathing, QT interval, MD, Chemoradiotherapy, Cough, Pemetrexed, Winship Cancer Institute, QT, OS, Electrolyte, Cardiomyopathy, Lung cancer, Safety, Emory University, CRT, LAURA, ILD, Patient, LVEF, Brain, Pharmaceutical industry

In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.

Key Points: 
  • In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.
  • Interstitial lung disease (ILD)/pneumonitis occurred in 4% of the 1813 TAGRISSO-treated patients; 0.4% of cases were fatal.
  • TAGRISSO is the only targeted therapy to improve patient outcomes in both early-stage disease in the ADAURA Phase III trial and late-stage disease in the FLAURA Phase III trial and FLAURA2 Phase III trial .
  • AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

Summary of opinion: Keytruda, 22/02/2024 Positive

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星期日, 三月 10, 2024
Carboplatin, GEJ, Hodgkin lymphoma, Patient, HNSCC, Cervical cancer, Ageing, CHL, Colorectal cancer, ALK, BTC, Head, Large intestine, Neck, Committee, Recurrence, IIC, Marketing, RCC, Renal cell carcinoma, Cancer, TPS, CHMP, Trastuzumab, TNBC, Paclitaxel, ASCT, Axitinib, Transitional epithelium, NSCLC, Lung cancer, European Commission, EGFR, Cholangiocarcinoma, Medication package insert, CRC, Neoplasm, Radiation, Cisplatin, Civil service commission, Pembrolizumab, Endometrial cancer, Nephrectomy, Platinum, MSI-H, Pemetrexed, Bevacizumab, Risk, Transitional cell carcinoma, CPS, PD-L1

Summary of opinion: Keytruda, 22/02/2024 Positive

Key Points: 


Summary of opinion: Keytruda, 22/02/2024 Positive

TAGRISSO® (osimertinib) with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer

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星期六, 二月 17, 2024
Oncology, FDA, Health, General Health, Pharmaceutical, Biotechnology, Heart, QT interval, Food, Pemetrexed, Risk, Cardiomyopathy, Electrolyte, Death, Patient, LVEF, Priority review, Pharmaceutical industry

This approval reinforces TAGRISSO as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.

Key Points: 
  • This approval reinforces TAGRISSO as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.
  • The safety profile of TAGRISSO with the addition of chemotherapy was generally manageable and consistent with the established profiles of the individual medicines.
  • Adverse event (AE) rates were higher in the TAGRISSO plus chemotherapy arm, driven by well-characterized chemotherapy-related AEs.
  • AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

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

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星期二, 一月 2, 2024
Immunotherapy, Lung cancer, Survival, Risk, ASCO, Shanda, Mortality, Shanghai Chest Hospital, Trial of the century, EFS, Society, Recurrence, Cisplatin, Cancer, MPR, HR, Death, Pemetrexed, World Health Organization, National Medical Products Administration, Patient, Diagnosis, Safety, Paclitaxel, NSCLC, PCR, Pharmaceutical industry

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.