FDA Approvals: ZYKADIA Supplemental Indication, STRATTERA first time generics
Week of May 29, 2017
SUPPLEMENTAL INDICATION: treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
REG PATHWAY: sNDA
- Original accelerated approval (2014) for patients with ALK-positive metastatic NSCLC whose disease has progressed or who are intolerant to crizotinib
- Open-label, randomized, active-controlled, multicenter study, LK-positive NSCLC patients with no prior systemic therapy (n=376), ZYKADIA vs chemotherapy plus maintenance chemotherapy
- Major efficacy outcome: Progression-free survival (PFS) determined by blinded independent review committee (BIRC) according to RECIST v1.1
- Additional efficacy outcomes: Overall survival (OS), overall response rate (ORR), duration of response (DOR) determined by BIRC, overall intracranial response rate (OIRR), duration of intracranial response (DOIR), and patient reported outcomes (PRO)
- PFS: 16.6 mo. vs. 8.1 mo., p-value <0.0001
- Confirmed ORR: 73% vs. 27%, Median DOR: 23.9 mo. vs. 11.1 mo., OSS: immature
- Overall OIRR: 57% vs, 22%, DOIR: 16.6 mo. vs. not estimable
- PRO Exploratory analyses: Delay in time to development/worsening of
shortness of breath with ZYKADIA
- Most common adverse reactions: Diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and cough
- Serious adverse reactions in 38%, discontinuation occurred in 12%, dose interruption due to adverse reactions 77%, dose reductions in 66%.
First generic versions of STRATTERA (atomoxetine)
Apotex Inc., Teva Pharmaceuticals, Aurobindo Pharma, Glenmark Pharmaceuticals
INDICATON: Treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients
REG PATHWAY: ANDA
- Most common side effects ( children and adolescents,): Upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings
- Most common side effects (adults): Constipation, dry mouth, nausea, decreased appetite, dizziness, sexual side effects, and problems passing urine.
- Boxed Warning : Increased risk of suicidal ideation
Image credits: Novartis, FDA