FDA Approves Libtayo® as Monotherapy for Advanced NSCLC
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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.
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
Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate adjuvanted recombinant protein-based COVID-19 vaccine candidate
New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults
If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021
In parallel, development work on new SARS-CoV-2 variants underway
PARIS and LONDON - February 22, 2021 - Sanofi and GSK announced today the initiation of a new Phase 2 study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase 3 evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
REPEAT Pure Extracts and Canada House Wellness Group sign agreement to distribute .
Pure Extracts Technologies Corp.February 18, 2021 GMT
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