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208434Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208434Orig1s000 MEDICAL REVIEW(S) Addendum to Clinical Review for NDA 208434 This addendum is regarding inclusion of “or intolerant to crizotinib” in the indication for alectinib. As discussed in the primary Clinical Review of this NDA, there was only one patient among those included in the efficacy assessments for Studies 1 and 2 documented to have discontinued crizotinib because of an adverse event (AE). During labeling negotiations, the Applicant provided additional information on this single phase II patient who was intolerant to crizotinib. In addition, the Applicant provided information on 4 patients enrolled in the Phase 1 part of Study 1 (NP28761) who enrolled onto study following discontinuation of crizotinib because of an AE. The following table, abstracted from information submitted by the Applicant, includes information for each patient on the AEs leading to discontinuation of crizotinib, the best overall radiologic response, and the duration of treatment with alectinib. A listing of treatment-emergent AEs experienced by these patients while receiving alectinib was also provided. Two of these patients, both participating in the Phase 1 part of the study, had alectinib dose reduced; one patient had 2 dose reductions, both for Grade 2 neutrophil decreased, and the other patient had dose reduced due to Grade 3 fluid retention. For both of these patients, treatment was ongoing at the time of primary analysis. The majority of AEs were Grade 1-2. Four Grade 3 AEs occurred among 3 of the 5 patients; one patient (Patient 10619)experienced Grade 3 fluid retention and hypokalemia, while Grade 3 hyperglycemia and Grade 3 pain in extremity occurred in one patient each (Patients 10407 and 10411, respectively). Reviewer comment: Patients 20613 and 10407 discontinued alectinib due to progression of disease after receiving treatment for 4.4 and 5.5 months, respectively. None of these 5 patients discontinued treatment with alectinib due to AE or inability to tolerate therapy. Three of these 5 patients were still receiving treatment with alectinib at the time of primary analysis with durations of treatment exceeding 15 months. While this data involves a small number of patients, based on the available information it is reasonable to include patients intolerant to crizotinib in the indication for alectinib. Reference ID: 3857952 --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- ERIN A LARKINS 12/09/2015 Reference ID: 3857952 Clinical Review Erin Larkins NDA 208434 Alecensa (alectinib) CLINICAL REVIEW Application Type NDA Application Number(s) 208434 Priority or Standard Priority Submit Date(s) July 6, 2015 Received Date(s) July 6, 2015 PDUFA Goal Date March 4, 2016 Division/Office DOP2/OHOP Reviewer Name(s) Erin Larkins Review Completion Date November 10, 2015 Established Name Alectinib (Proposed) Trade Name Alecensa Applicant Hoffmann-La Roche Formulation(s) 150 mg capsules Dosing Regimen 600 mg orally twice daily Applicant Proposed Treatment of patients with anaplastic lymphoma kinase (ALK)- Indication(s)/Population(s) positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Recommendation on Accelerated Approval Regulatory Action Recommended Treatment of patients with anaplastic lymphoma kinase (ALK)- Indication(s)/Population(s) positive metastatic non-small cell lung cancer (NSCLC) who have (if applicable) progressed on crizotinib CDER Clinical Review Template 2015 Edition 1 Version date: June 25, 2015 for initial rollout (NME/original BLA reviews) Reference ID: 3845599 Clinical Review Erin Larkins NDA 208434 Alecensa (alectinib) Table of Contents Glossary ..........................................................................................................................................9 1 Executive Summary...............................................................................................................11 1.1. Product Introduction......................................................................................................11 1.2. Conclusions on the Substantial Evidence of Effectiveness.............................................11 1.3. Benefit-Risk Assessment ................................................................................................11 2 Therapeutic Context..............................................................................................................19 2.1. Analysis of Condition......................................................................................................19 2.2. Analysis of Current Treatment Options .........................................................................20 3 Regulatory Background .........................................................................................................21 3.1. U.S. Regulatory Actions and Marketing History.............................................................21 3.2. Summary of Presubmission/Submission Regulatory Activity ........................................21 3.3. Foreign Regulatory Actions and Marketing History .......................................................24 4 Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety ................................................................................................................24 4.1. Office of Scientific Investigations (OSI) ..........................................................................24 4.2. Product Quality ..............................................................................................................26 4.3. Clinical Microbiology......................................................................................................26 4.4. Nonclinical Pharmacology/Toxicology ...........................................................................26 4.5. Clinical Pharmacology ....................................................................................................26 4.5.1. Mechanism of Action..............................................................................................26 4.5.2. Pharmacodynamics.................................................................................................26 4.5.3. Pharmacokinetics....................................................................................................27 4.6. Devices and Companion Diagnostic Issues ....................................................................28 4.7. Consumer Study Reviews...............................................................................................28 5 Sources of Clinical Data and Review Strategy .......................................................................29 5.1. Table of Clinical Studies .................................................................................................29 5.2. Review Strategy .............................................................................................................29 6 Review of Relevant Individual Trials Used to Support Efficacy .............................................30 CDER Clinical Review Template 2015 Edition 2 Version date: June 25, 2015 for initial rollout (NME/original BLA reviews) Reference ID: 3845599 Clinical Review Erin Larkins NDA 208434 Alecensa (alectinib) 6.1. Study NP28761...............................................................................................................30 6.1.1. Study Design ...........................................................................................................30 6.1.2. Study Results ..........................................................................................................49 6.2. NP28673.........................................................................................................................55 6.2.1. Study Design ...........................................................................................................55 6.2.2. Study Results ..........................................................................................................66 6.3. AF-001JP.........................................................................................................................72 6.3.1. Study Design ...........................................................................................................72 6.3.2. Study Results ..........................................................................................................74 7 Integrated Review of Effectiveness.......................................................................................78 7.1. Assessment of Efficacy Across Trials..............................................................................78 7.1.1. Primary Endpoints ..................................................................................................78 7.1.2. Secondary and Other Endpoints.............................................................................78 7.1.3. Subpopulations.......................................................................................................81 7.1.4. Dose and Dose-Response
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