LIBTAYO

批准信原文要点

notifying you, under Section 505(o)(4)… serious risk of Myocarditis-Myositis-Myasthenia Gravis Overlap Syndrome. This sBLA provides for revisions to the labeling for Libtayo…

批准信原文要点

This Prior Approval supplemental biologics license application updates the Libtayo (cemiplimab-rwlc) prescribing information (PI) with data from study R2810-ONC-1690 in Section 8.4: Pediatric Use.

批准信原文要点

This Prior Approval supplemental biologics license application provides an update to the Libtayo (cemiplimab-rwlc) prescribing information (PI) and medication guide (MG) with a new indication for the adjuvant treatment of patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

批准信原文要点

This Prior Approval supplemental biologics license application provides for changes to the Libtayo (cemiplimab) Prescribing Information (USPI) in section 14.2 Basal Cell Carcinoma (BCC) updating the metastatic BCC efficacy data. The application also adds “virus” to the (type of) influenza A test for clarity in section 6.1 Clinical Trials Experience, under Table 2 in the labeling, in addition to correcting minor punctuation errors.

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notifying you, under Section 505(o)(4)… risk of transplant (including corneal graft) rejection… This supplemental biologics license application provides for revisions to the labeling for Libtayo…

批准信原文要点

This Prior Approval supplemental biologics license application provides an update to the Libtayo prescribing information (PI) and Medication Guide (MG) with data supporting the fulfillment of postmarketing requirement 4012-1 for the metastatic basal cell carcinoma indication (mBCC).

批准信原文要点

This Prior Approval supplemental biologics license application provides an update to the Libtayo prescribing information (PI) and Medication Guide (MG) with data supporting the fulfillment of postmarketing commitment 3489-1 for the cutaneous squamous cell carcinoma indication.

批准信原文要点

This Prior Approval sBLA provides for a new indication for Libtayo (cemiplimab-rwlc), in combination with platinum-based chemotherapy, for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic.

批准信原文要点

This Prior Approval supplemental biologics application provides for a new indication for the first-line treatment of patients with non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: locally advanced where patients are not candidates for surgical resection or metastatic.

批准信原文要点

This Prior Approval supplemental biologics application provides for a new indication for cemiplimab-rwlc, for the treatment of patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.

批准信原文要点

This Prior Approval supplemental biologics application provides for a new indication for cemiplimab-rwlc, for the treatment of patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.

批准信原文要点

This Prior Approval supplemental biologics application provides for revisions to the U.S. prescribing information and medication guide to improve the presentation of drug safety information regarding immune-mediated adverse reactions across all FDA approved PD-L1 and PD-1 blocking antibody labels.

批准信原文要点

This Prior Approval supplemental biologics application revises the Clinical Studies (14) section of the prescribing information to include additional response data from Trials R2810-ONC-1540 and R2810-ONC-1423.

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This “Chang Being Effected” supplemental biologics license application provides for an update to remove the 250 mg/5 mL (50 mg/mL) dosage formulation from the Prescribing Information, container label, carton labeling, and Module 3.2.P.

批准信原文要点

This Prior Approval supplemental biologics application provides for revisions to the CLINICAL PHARMACOLOGY, Pharmacokinetics (12.3) subsection ... to provide revised creatinine clearance information under the heading Specific Populations.