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Cemiplimab Gets FDA Nod for NSCLC | Physician s Weekly

Feb 24, 2021 This is the third approval for the immunotherapy Cemiplimab (Libtayo) has garnered FDA approval for the first-line treatment of patients with non-small cell lung cancer (NSCLC) with tumors with high PD-L1 expression, according to a statement from Regeneron Pharmaceuticals and Sanofi. “[Cemiplimab] has demonstrated an impressive level of efficacy in advanced NSCLC with at least 50% PD-L1 expression in its pivotal trial,” said Ahmet Sezer, MD, of Başkent University in Adana, Turkey, who was a trial investigator. “As published in The Lancet, in a prespecified analysis in the subset of patients proven to have PD-L1 expression of at least 50%, [cemiplimab] reduced the risk of death by 43% compared to chemotherapy. This was achieved with a greater than 70% crossover rate to [cemiplimab] following disease progression on chemotherapy, as well as the largest population of patients with pretreated and clinically stable brain metastases among advanced NSCLC pivotal tria

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FDA Approves Libtayo® as Monotherapy for Advanced NSCLC

FDA Approves Libtayo® as Monotherapy for Advanced NSCLC Search jobs Subject: FDA Approves Libtayo Regeneron and Sanofi received U.S. FDA approval for Libtayo® (cemiplimab-rwlc, an PD-1 inhibitor) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), %), as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations. This NSCLC indication is the third FDA approval for LIBTAYO and follows another approval earlier this month for patients with advanced basal cell carcinoma previously treated with a hedgehog inhibitor (HHI) or for whom a HHI is not appropriate.

Naiyer rizviPeterc adamsonGeorged yancopoulosAhmet sezerColumbia university irving medical centerTeva pharmaceutical industries ltdLibtayo development programVirtual congressGlobal development headRegeneron pharmaceuticalsRegeneron pharmaceuticals incRegeneron genetics centerEuropean commissionDrug administrationClinical sciencesDepartment of medical oncology

Sanofi: FDA approves Libtayo (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of =50%

Sanofi: FDA approves Libtayo (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of =50% N=356 a 14 months Median (95% CI) b Based on stratified proportional hazards model An additional prespecified analysis was performed in 563 patients with proven PD-L1 expression of =50%, according to the FDA-approved assay, and is described in the updated labeling of the FDA-approved assay (and also recently published (https://www.sanofi.com/en/media-room/press-releases/2021/2021-02-12-07-00-00) in The Lancet). This analysis showed that Libtayo reduced the risk of death by 43% compared to chemotherapy, with additional efficacy results as follows: Endpoints

France generalEva schaefer jansenSuzanne grecoArnaud delepineFelix lauscherYvonne naughtonVesna tosicFara berkowitzNaiyer rizviPeterc adamsonSally bainDaren kwokAhmet sezerRegeneron pharmaceuticals incRegeneron genetics centerEuropean commission

FDA Approves Libtayo® (cemiplimab-rwlc) Monotherapy for Patients with First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%

/PRNewswire/ Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics.

France generalNaiyer rizviPeterc adamsonGeorged yancopoulosRegeneron velocimmuneAhmet sezerRegeneron pharmaceuticalsRegeneron pharmaceuticals incRegeneron genetics centerEuropean commissionDrug administrationClinical sciencesDepartment of medical oncology at baTeva pharmaceutical industries ltdExchange commissionEuropean medicines agency

Cemiplimab monotherapy in advanced non-squamous and squamous non-small cell lung cancer

Cemiplimab monotherapy in advanced non-squamous and squamous non-small cell lung cancer
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