IMFINZI

批准信原文要点

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

批准信原文要点

This Prior Approval sBLA adds the following new indication: IMFINZI, in combination with Bacillus Calmette Guérin (BCG), for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC)

批准信原文要点

This Prior Approval supplemental biologics license application adds the following new indication: IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single-agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

批准信原文要点

IMFINZI, in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC).

批准信原文要点

This Prior Approval supplemental biologics license application provides for the following changes: to inform the FDA of the approval of the PMA supplement for the VENTANA MMR RxDxPanel as a CDx which, the Applicant believes fulfills PMC# 4653-2, and to update the IMFINZI USPI to reflect the availability of the FDA-approved test for the detection of dMMR status in endometrial cancer.

批准信原文要点

This Prior Approval sBLA provides for a new indication for Imfinzi (durvalumab) injection, as a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

批准信原文要点

This Prior Approval sBLA provides for the following new indication of Imfinzi, in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by Imfinzi continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

批准信原文要点

This Prior Approval supplemental biologics application updates the United States Prescribing Information (USPI) and structured product labeling (SPL) with the results from study D419EC00001... Changes are to the Pediatric Use subsection of the “USE IN SPECIFIC POPULATIONS” section of the labeling.

批准信原文要点

This Prior Approval supplemental biologics license application provides a new indication for the use of Imfinzi in combination with carboplatin and paclitaxel followed by Imfinzi as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

批准信原文要点

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 Imfinzi…

批准信原文要点

This Prior Approval supplemental biologics application provides for updates to the Medication Guide to add information for patients regarding the symptoms of immune-mediated arthritis.

批准信原文要点

This Prior Approval sBLA provides for minor administrative changes in the US Prescribing Information labeling, and revision to the Medication Guide aligning the possible side effects of Imfinzi with that of Imjudo (tremelimumab) for combination treatment of patients with non-small cell lung cancer.

批准信原文要点

This Prior Approval sBLA provides for a new indication for Imfinzi, in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

批准信原文要点

This Prior Approval supplemental biologics license application provides for a new indication for Imfinzi in combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma.

批准信原文要点

This Prior Approval supplemental biologics license application provides for a new indication using Imfinzi in combination with gemcitabine and cisplatin for the treatment of adult patients with locally advanced or metastatic biliary tract cancer.

批准信原文要点

This Prior Approval supplemental biologics application provides for revisions to Section 17, Patient Counseling Information, to include pancreatitis and encephalitis.

批准信原文要点

This Prior Approval sBLA provides for revisions to Section 5 Warnings and Precautions subsection 5.1 Immune-Mediated Adverse Reactions of the USPI, to update the incidence of select immune-mediated adverse reactions using an automated process with minor updates to the Highlights of Prescribing Information.

批准信原文要点

This Prior Approval supplemental biologics application provides for removal of the following indication, previously approved under accelerated approval: the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

批准信原文要点

These Prior Approval supplementals biologics application provide for the addition of alternate treatment schedule of 1500 mg every 4 weeks for stage 3 unresectable non-small cell lung cancer and urothelial carcinoma. In addition to the new alternate treatment schedule, these Prior Approval Supplements also provide for the update to the US Prescribing Information to include the preferred term, “Immune thrombocytopenia” to Section 5.7 Other Immune-Mediated Adverse Reactions and Section 17 Patient Counseling Information.

批准信原文要点

These Prior Approval supplementals biologics application provide for the addition of alternate treatment schedule of 1500 mg every 4 weeks for stage 3 unresectable non-small cell lung cancer and urothelial carcinoma.

批准信原文要点

These Prior Approval supplementals biologics application provide for the addition of alternate treatment schedule of 1500 mg every 4 weeks for stage 3 unresectable non-small cell lung cancer and urothelial carcinoma.

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 Food and Drug Administration (FDA) approved programmed death-ligand 1 and programmed cell death protein 1 blocking antibody labels.

批准信原文要点

This Prior Approval supplemental biologics application provides for updates to the US Prescribing Information (USPI) to include myasthenia gravis as an adverse reaction in Sections 2.2 (Dosage and Administration-Dosage Modifications), 5.7 (Warnings and Precautions-Other Immune-Mediated Adverse Reactions), and 17 (Patient Counseling Information).

批准信原文要点

This Prior Approval supplemental biologics application provides for a new indication for the use of IMFINZI, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

批准信原文要点

This Prior Approval supplemental biologics license application provides for the extension of in-use time at room temperature.

批准信原文要点

This Prior Approval supplemental biologics application provides for updates to the overall survival data for the PACIFIC trial (14.2) and modifications to the Adverse Reactions, Immunogenicity (6.2) section of the package insert to remove the statement regarding assay performance and clarify the source of the data for immunogenicity.

批准信原文要点

This Prior Approval supplemental biologics application provides for a new indication, for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.