7/20/2017
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`Approved Drugs > Erlotinib (Tarceva)
`
`Erlotinib (Tarceva)
`
`On October 18, 2016, the U.S. Food and Drug Administration modified the indication for erlotinib (TARCEVA,
`Astellas Pharm Global DevelopmentInc.) for treatment of non-small cell lung cancer (NSCLC) to limit use to
`patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations.
`
`The labeling change applies to patients with NSCLC receiving maintenance or second or greater line treatment.
`Theseindications will be limited to those patients whose tumors have EGFR exon 19 deletions or exon 21 L858R
`substitution mutations as detected by an FDA-approvedtest. The first-line indication previously waslimited to
`patients with EGFR exon 19 deletions or exon 21 substitution mutations.
`
`This labeling supplement is based on the results of the IUNO trial, a randomized, double-blind, placebo-controlled,
`trial of erlotinib administered as maintenance therapy in 643 patients with advanced NSCLC who had not
`experienced disease progression or unacceptable toxicity during four cycles of platinum-basedfirst-line
`chemotherapy. Patients whose tumors harbored activating EGFR mutations (exon 19 deletions or exon 21 L858R
`mutations) were excluded from this trial. Patients were randomized 1:1 to receive erlotinib or placebo orally once
`daily (322 erlotinib, 321 placebo) until disease progression or unacceptable toxicity. Following progression oninitial
`therapy, patients were eligible to enter an open-label phase. Fifty percent of patients randomized to erlotinib
`entered the open-label phase and received chemotherapy, while 77% of patients randomized to placebo entered
`the open-label phase and receivederlotinib.
`
`Thetrial’s primary endpoint was overall survival. Results demonstrated that survival following treatment with
`erlotinib was not better than placebo administered as maintenancein patients with metastatic NSCLC tumors not
`harboring EGFR-activating mutations. No difference in progression-free survival betweenthe erlotinib arm and the
`placebo arm wasobserved.
`
`FDAwill not require new post-marketing requirements or request post-marketing commitments based on the results
`of the IUNO trial.
`
`Full prescribing information is available at:
` (http:liwww.accessdata,fda,gov/drugsatfda docs/label/2016/021743s025IbI,pdf)
`
`Healthcare professionals should report all serious adverse events suspected to be associated with the use of any
`medicine and device to FDA’s MedWatch Reporting System by completing a form online at
`http://www.fda.gov/medwatch/report.htm (http://www.fda.gov/medwatch/report.htm), by faxing (1-800-FDA-
`0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
`
`More in_ Approved Drugs
`/Drugs/InformationOnDrugs/ApprovedDrugs/default.htm
`
`Cancer) Approvals & Safety Notifications
`Hematology/Oncolo
`/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm
`
`https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm525739.htm
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`APOTEX EX. 1052-001
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`1/2
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`APOTEX EX. 1052-001
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`7/20/2017
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`Approved Drugs > Erlotinib (Tarceva)
`
`
`
`Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
`/Drugs/InformationOnDrugs/ApprovedDrugs/ApprovedDrugProductswithTherapeuticEquivalenceEvaluationsOrangeBook/default.hti
`
`https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm525739.htm
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`APOTEX EX. 1052-002
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`2/2
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`APOTEX EX. 1052-002
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