Pemetrexed

AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) PLUS CHEMOTHERAPY DATA IN FIRST-LINE KRAS G12C NSCLC AT WCLC

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Dimanche, septembre 10, 2023
WCLC, AMGN, KRAS, Duke University, Amgen, Duke Cancer Institute, DCR, Platinum, Trae tha Truth, Lung cancer, International Association, Medicine, NSCLC, Carboplatin, PFS, Drug resistance, Progression-free survival, Patient, Anemia, Heath Robinson (codebreaking machine), Pemetrexed, Safety, PD-L1, Conference, ORR, Pharmaceutical industry, Fine chemical, Research

THOUSAND OAKS, Calif., Sept. 10, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced exciting data from a study arm of the CodeBreaK 101 clinical trial, a Phase 1b study evaluating LUMAKRAS® (sotorasib) with carboplatin and pemetrexed in adult patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These results were featured in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) in Singapore on Sunday, September 10.

Key Points: 
  • In assessable patients in the second-line setting (n=13), the ORR was 54%, with a DCR of 85% (95% CI: 54.6, 98.1).
  • "Notably, these results follow and further expand upon the Phase 2 investigator-led data demonstrating favorable efficacy and safety of LUMAKRAS plus carboplatin and pemetrexed in the first-line treatment of patients with KRAS G12C-mutated NSCLC."
  • The LUMAKRAS plus chemotherapy combination reported treatment-related adverse events (TRAEs) consistent with LUMAKRAS and other platinum doublet-based approaches.
  • "The CodeBreaK 101 results show exciting efficacy with sotorasib plus chemotherapy and, importantly for a combination treatment, a safety profile consistent with the individual therapies.

Eagle Pharmaceuticals Reports Second Quarter 2023 Results

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Mardi, août 8, 2023
Share repurchase, QIDP, Bronchopneumonia, Marketing, Food, Eagle, Type, Acquisition, Patient, Growth, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Pemetrexed, Tariff, Safety, Breast cancer, Film industry, Video game, Pharmaceutical industry, Tutoring, Remimazolam

“We delivered a strong second quarter with impressive earnings and revenue, continuing the positive trajectory from an outstanding 18 months of business performance,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Key Points: 
  • “We delivered a strong second quarter with impressive earnings and revenue, continuing the positive trajectory from an outstanding 18 months of business performance,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
  • Depending upon recruitment rates, Eagle anticipates having its 50% interim report around the first half of 2024.
  • Total revenue for the second quarter of 2023, was $64.6 million, as compared to $74.1 million for the second quarter of 2022.
  • Second quarter 2023 royalty revenue was $21.7 million, compared to $24.9 million in the prior year quarter.

Datopotamab Deruxtecan Met Dual Primary Endpoint of Progression-Free Survival in Patients With Advanced Non-Small Cell Lung Cancer in TROPION-Lung01 Phase III Trial

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Lundi, juillet 3, 2023
Research, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, International, Cleavage, World Health Organization, Lead, MD, Patient, Immunoglobulin G, EGFR, Daiichi Sankyo, Spacecraft, ALK, Pharmacotherapy, Pircher, Observational study, Lung cancer, HIV disease progression rates, ADC, Immunology, PD-1, Death, PD-L1, Safety, Docetaxel, Medicine, Treatment of lung cancer, Immunotherapy, PFS, Sapporo Medical University, Gefitinib, Pemetrexed, Triple-negative breast cancer, Metabolism, Progression-free survival, International Agency for Research on Cancer, OS, Biopharmaceutical, AstraZeneca, Lung, Rare, DXD, American Cancer Society, Treatment, Breast cancer, Medical imaging, Pharmaceutical industry, Fine chemical, Nursing, Mineral wool, Cancer, NSCLC

The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified.
  • Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.
  • Patients without actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
  • AstraZeneca is also researching a potential diagnostic test to help identify patients most likely to benefit from treatment with datopotamab deruxtecan.

Eagle Pharmaceuticals Provides Business Update and Reiterates 2023 Guidance

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Jeudi, juin 15, 2023
Acacia, Maintenance, Food and Drug Administration Safety and Innovation Act, QIDP, Bronchopneumonia, Marketing, Food, Eagle, Progress, GAIN, Vomiting, Acquisition, Patent, PONV, Patient, Physician, NCE, Nursing, Growth, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Pemetrexed, Tariff, Safety, Breast cancer, Pharmaceutical industry, Remimazolam

“As we approach midyear 2023, our business remains strong, and we are pleased with the positive growth trajectory in our key commercial products. Through our well-trained and experienced sales force -- made up of 50 reps on the hospital side of the business and 25 focused on oncology -- for the quarter to date, Barhemsys® and Byfavo® have already topped the sales number posted in the first quarter of 2023, and PEMFEXY® has achieved an 18% market share in early Q2. We are pleased to see these two assets gaining uptake in the hospital and reflecting the value we saw when we originally decided to make the acquisition,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Key Points: 
  • WOODCLIFF LAKE, N.J., June 15, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today provided a business update and reiterated its 2023 financial guidance.
  • “As we approach midyear 2023, our business remains strong, and we are pleased with the positive growth trajectory in our key commercial products.
  • Eagle anticipates continued growth in net sales of PEMFEXY in the remainder of 2023 as compared to 2022.
  • Guidance: The Company reaffirms previously provided 2023 full-year guidance.

Amneal Receives 505(b)(2) NDA Approval from FDA for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable

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Mercredi, juin 14, 2023
Oncology, Health, FDA, Manufacturing, Clinical Trials, Other Manufacturing, Pharmaceutical, Radiation, Centers for Medicare & Medicaid Services, Mesothelioma, NDA, Refrigeration, Kidney, Cisplatin, Aplastic anemia, Medication, Medicare, Patient, Risk, Pembrolizumab, SVP, Regulation of tobacco by the U.S. Food and Drug Administration, Pemetrexed, RTU, NYSE, Food, Approximation error, Disease, ALK, Pharmaceutical industry

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the 505(b)(2) New Drug Application (NDA) approval from the U.S. Food and Drug Administration (“FDA”) for PEMRYDI RTU®.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the 505(b)(2) New Drug Application (NDA) approval from the U.S. Food and Drug Administration (“FDA”) for PEMRYDI RTU®.
  • This injectable will be available in three vial sizes: 100mg/10mL; 500 mg/50mL; and 1,000mg/100mL.
  • “We believe PEMRYDI RTU, the first ready-to-use version of a key oncology injectable, will offer a meaningful advantage in this improved presentation.
  • This approval represents another high-value product for our growing injectables portfolio which we expect to launch with a J-code for PEMRYDI RTU,” said Harsher Singh, SVP of Amneal Biosciences.

KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone as First-Line Treatment for Unresectable Advanced Pleural Mesothelioma

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Samedi, juin 3, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Survival rate, Progression-free survival, RECIST, OS, MRK, Quality of life, Multimedia, Research, Cisplatin, Carboplatin, PFS, Merck & Co., ASCO, National Cancer Institute, NCIN, Investigational New Drug, American Society of Clinical Oncology, Patient, Risk, AUC, Annual general meeting, Pemetrexed, Mesothelioma, Pembrolizumab, Death, Society, PD-L1, NYSE, ORR, Safety, Pharmaceutical industry, Platinum, Merck

The trial evaluated KEYTRUDA plus chemotherapy versus chemotherapy alone for the treatment of patients with unresected advanced pleural mesothelioma.

Key Points: 
  • The trial evaluated KEYTRUDA plus chemotherapy versus chemotherapy alone for the treatment of patients with unresected advanced pleural mesothelioma.
  • PFS was also significantly improved for KEYTRUDA plus chemotherapy compared to chemotherapy alone (HR=0.80 [95%CI, 0.65-0.99], two-sided p value = 0.0372; median PFS 7.13 months versus 7.16 months respectively).
  • At 12 months, the estimated PFS rate was 26% for KEYTRUDA plus chemotherapy versus 17% for chemotherapy alone.
  • The ORR was significantly higher for KEYTRUDA plus chemotherapy versus chemotherapy alone (62% versus 38%, p

Genprex Publishes Positive Clinical Data from Phase 1 Portion of Acclaim-1 Clinical Trial Evaluating REQORSA® Immunogene Therapy in Non-Small Cell Lung Cancer at the 2023 ASCO Annual Meeting

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Jeudi, mai 25, 2023
Diabetes, Clinical trial, Cancer, NSCLC, Carboplatin, PFS, ASCO, American Society of Clinical Oncology, MD, Patient, EGFR, Annual general meeting, Toxic leukoencephalopathy, Pemetrexed, Society, PR, Safety, Disease, Pharmaceutical industry

AUSTIN, Texas, May 25, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that positive data from the Phase 1 portion of its Acclaim-1 clinical trial evaluating REQORSA® Immunogene Therapy in combination with Tagrisso® in late-stage non-small cell lung cancer (NSCLC) were published in an abstract at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023 in Chicago, IL and online.

Key Points: 
  • "We are thrilled to have our abstract, which reports positive results from the Phase 1 portion of our Acclaim-1 clinical trial, published at the ASCO Annual meeting," said Mark Berger, MD, Chief Medical Officer at Genprex.
  • Full safety and efficacy data on the Phase 1 portion of the study will be presented at an upcoming medical meeting.
  • While the Phase 1 portion of the clinical trial is designed primarily to assess safety, promising efficacy results were also observed.
  • PFS is the primary endpoint of both the Phase 2 expansion portion and the Phase 2 randomized portion of the Acclaim-1 trial.

Summit Therapeutics Announces First Patient Treated in Phase III HARMONi Clinical Trial Evaluating Ivonescimab (SMT112)

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Mardi, mai 9, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Progression-free survival, Lung cancer, TKI, NSCLC, Carboplatin, Immunotherapy, Institutional review board, PFS, Trial of the century, VEGF, Patient, EGFR, TME, SMMT, Neoplasm, PD-1, FDA, Courage, Phase, Pemetrexed, Tumor microenvironment, Safety, Pharmaceutical industry, Nursing, Medical imaging, Paranal Observatory

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that the first United States-based patient has been enrolled in the Phase III HARMONi study.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that the first United States-based patient has been enrolled in the Phase III HARMONi study.
  • HARMONi is a Phase III multiregional, randomized, double-blinded study.
  • Specifically, the study will compare ivonescimab combined with pemetrexed and carboplatin chemotherapies against a placebo plus pemetrexed and carboplatin.
  • Over 750 patients have been treated with ivonescimab across multiple clinical studies in China and Australia.

Eagle Pharmaceuticals Reports First Quarter 2023 Results

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Mardi, mai 9, 2023
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WOODCLIFF LAKE, N.J., May 09, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three months ended March 31, 2023.

Key Points: 
  • WOODCLIFF LAKE, N.J., May 09, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three months ended March 31, 2023.
  • Net product sales of PEMFEXY totaled $22.9 million in the first quarter 2023.
  • Inventory on hand is expected to be depleted by the end of the second quarter of 2023.
  • Q1 2023 royalty revenue was $20.1 million, compared to $25.8 million in the prior year quarter.

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

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Mercredi, avril 12, 2023
Survival rate, IDMC, Cancer, Lung cancer, NSCLC, Cisplatin, Immunotherapy, Trial of the century, ASCO, SSE, HKEX, Patient, National Medical Products Administration, EFS, Diagnosis, Mortality, Shanghai Chest Hospital, Recurrence, Death, III, Pemetrexed, World Health Organization, Disease, Pharmaceutical industry

“This newly applied indication for operable NSCLC patients will open the door to the clinical application of toripalimab in the early stages of the disease,”said Dr. Jianjun ZOU, President of Global Research and Development at Junshi Biosciences.

Key Points: 
  • “This newly applied indication for operable NSCLC patients will open the door to the clinical application of toripalimab in the early stages of the disease,”said Dr. Jianjun ZOU, President of Global Research and Development at Junshi Biosciences.
  • “The Neotorch study has created a new model of perioperative immunotherapy for NSCLC in China, enabling the use of immunotherapy throughout the preoperative, postoperative, and consolidation maintenance processes.
  • Neotorch is the world’s first phase III registered study demonstrating that perioperative treatment with anti-PD-1 monoclonal antibody significantly extends EFS of patients with operable NSCLC.
  • Results of the interim analysis showed that, compared with chemotherapy alone, toripalimab in combination with chemotherapy as perioperative treatment for stage III operable NSCLC patients and toripalimab monotherapy for consolidation therapy thereafter could significantly extend EFS of patients.