Week of May 29, 2017

FDA approved


Brand logo alt

ZYKADIA (ceritinib)

Novartis

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

EFFICACY:

  • 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

SAFETY:

  • 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%.

LABEL  


First Time Generic

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

SAFETY:

  • 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

LABEL


Image credits: Novartis, FDA

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