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Replimune Reports Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update
2/8/2024
Replimune Reports Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update.
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Fianlimab (LAG-3 inhibitor) Combined with Libtayo® (cemiplimab) Shows Clinically Meaningful and Durable Tumor Responses Across Key Advanced Melanoma Patient Populations
5/25/2023
Regeneron Pharmaceuticals, Inc. announced positive data from three independent cohorts evaluating an investigational combination of LAG-3 inhibitor fianlimab and PD-1 inhibitor Libtayo® in adults with advanced melanoma.
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Regeneron ESMO IO Presentations Highlight Potential of Fianlimab and Libtayo® (cemiplimab) in Multiple Solid Tumor Types
12/1/2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2022 from December 7 to 9 in Geneva, Switzerland.
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Libtayo® (cemiplimab) Approved by the European Commission as the First Immunotherapy in Second Line Recurrent or Metastatic Cervical Cancer Irrespective of PD-L1 Expression Level or Tumor Histology
11/22/2022
Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or metastatic cervical cancer, with Libtayo reducing the risk of death by 31% compared to chemotherapy during the study.
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Libtayo® (cemiplimab) Approved by the European Commission as the First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma
6/25/2021
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has approved the PD-1 inhibitor Libtayo® to treat adults with locally advanced or metastatic basal cell carcinoma who have progressed on or are intolerant to a hedgehog pathway inhibitor.
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Sanofi: Libtayo® (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma
6/25/2021
The European Commission has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo® to treat adults with locally advanced or metastatic basal cell carcinoma who have progressed on or are intolerant to a hedgehog pathway inhibitor.
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Sanofi’s experimental breast cancer treatment amcenestrant in combination with Pfizer’s Ibrance is showing promising anti-tumor activity in postmenopausal women with metastatic breast cancer.
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Libtayo® (cemiplimab) Receives Positive CHMP Opinion for the Treatment in Europe of Two Advanced Cancers
5/24/2021
Libtayo recommended for approval in the first-line treatment of certain patients with advanced non-small cell lung cancer whose tumors have ≥50% PD-L1 expression
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Libtayo® (cemiplimab-rwlc) Presentations at ASCO Highlight Expanding Clinical Data in Diverse Cancers
5/19/2021
Regeneron Pharmaceuticals, Inc. announced the company will share a range of presentations for its PD-1 inhibitor Libtayo® and broader oncology portfolio at the 2021 American Society of Clinical Oncology Annual Meeting from June 4-8, taking place virtually.
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Phase 3 Trial of Libtayo® (cemiplimab) Monotherapy in Advanced Cervical Cancer Stopped Early for Positive Result on Overall Survival
3/15/2021
Libtayo is the first immunotherapy to demonstrate improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared to chemotherapy
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On Monday, the companies announced their checkpoint inhibitor Libtayo (cemiplimab-rwlc) won Food and Drug Administration approval for lung cancer.
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FDA Approves Libtayo® (cemiplimab-rwlc) Monotherapy for Patients with First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%
2/22/2021
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression
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Findings from a pivotal trial published in The Lancet show Libtayo® (cemiplimab), a PD-1 inhibitor jointly developed and commercialized by Regeneron Pharmaceuticals and Sanofi, was superior to platinum-doublet chemotherapy for improving overall survival in patients with locally advanced or metast...
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The U.S. FDA has approved Regeneron and Sanofi’s PD-1 inhibitor Libtayo® for the treatment of patients with advanced basal cell carcinoma with a history of treatment with a hedgehog pathway inhibitor or in patients with advanced BCC who are considered ineligible for an HHI.
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FDA Approves Libtayo® (cemiplimab-rwlc) as First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma
2/9/2021
Following Priority Review Libtayo receives full approval in locally advanced basal cell carcinoma (BCC) and accelerated approval in metastatic BCC Libtayo now approved for patients with advanced stages of the two most common skin cancers in the U.S. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sano
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FDA Accepts for Priority Review Libtayo® (cemiplimab-rwlc) for Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%
10/29/2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.
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Late-breaking ESMO Presentation Shows Libtayo® (cemiplimab) Monotherapy Increases Overall Survival in First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%
9/21/2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the presentation of positive pivotal trial data for the investigational use of PD-1 inhibitor Libtayo® (cemiplimab) in first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
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Positive Pivotal Data for Libtayo® (cemiplimab) Monotherapy in Locally Advanced Basal Cell Carcinoma Featured as a Late-breaking Presentation at ESMO
9/18/2020
Regeneron Pharmaceuticals, Inc. and Sanofi announced the presentation of positive results from the pivotal Phase 2 trial for the PD-1 inhibitor Libtayo® in patients with locally advanced basal cell carcinoma who had progressed on or were intolerant to hedgehog inhibitor therapy.
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Late-breaking Libtayo® (cemiplimab) Pivotal Data in Advanced Non-small Cell Lung Cancer and Basal Cell Carcinoma to Be Presented at ESMO
9/3/2020
Regeneron Pharmaceuticals, Inc. and Sanofi announced the presentation of new, positive data for the PD-1 inhibitor Libtayo® at the European Society for Medical Oncology Virtual Congress 2020 from September 19-21.
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New Publication Highlights Preclinical Research Showing Potential to Enhance Cancer Treatment by Combining Novel Costimulatory Bispecific Antibodies with Libtayo® (cemiplimab)
6/24/2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced new scientific findings have been highlighted today in a Science Translational Medicine cover publication.