`
`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 Development Inc.) 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.
`These indications will be limited to those patients whose tumors have EGFR exon 19 deletions or exon 21 L858R
`
`substitution mutations as detected by an FDA-approved test. The first-line indication previously was limited 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-based first-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 on initial
`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 received erlotinib.
`
`The trial’s primary endpoint was overall survival. Results demonstrated that survival following treatment with
`erlotinib was not better than placebo administered as maintenance in patients with metastatic NSCLC tumors not
`harboring EGFR-activating mutations. No difference in progression-free survival between the erlotinib arm and the
`placebo arm was observed.
`
`FDA will 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:
`
`htt
`:llwww.accessdata.fda. ovldru satfda docs/labell2016/0217433025lbl. df
`
`(http:llwww.accessdata.fda.govld rugsatfda docs/labell2016/0217435025lbl.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:llwww.fda.govlmedwatchlreport.htm 1http:llwww.fda.govlmedwatchlreport.htm1, 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
`lDru sllnformationOnDru sIA rovedDru sldefault.htm
`
`Cancer A rovals&Safet Notifications
`IOncolo
`Hematolo
`lDru sllnformationOnDru sIA rovedDru slucm279174.htm
`
`https://www.fda.gov/Drugs/lnformationOnDrugs/ApprovedDrugs/ucm525739.htm
`
`1/2
`
`APOTEX EX. 1052-001
`
`APOTEX EX. 1052-001
`
`
`
`7/20/2017
`
`Approved Drugs > Erlotinib (Tarceva)
`
`
`Dru Information Soundcast in Clinical Oncolo
`D.I.S.C.O.
`IDru sllnformationOnDru slA rovedDru slucm558268.htm
`
`Approved Drug Products with Therapeutic Eguivalence Evaluations (Orange Book)
`/Dru sllnformationOnDru s/A rovedDru s/A rovedDru ProductswithThera euticE uivalenceEvaIuationsOran eBook/defa’ulthtl
`
`https://www.fda.gov/Drugs/lnformationOnDrugs/ApprovedDrugs/ucm525739.htm
`
`2/2
`
`APOTEX EX. 1 052-002
`
`APOTEX EX. 1052-002
`
`