OSIMERTINIB TAB
Clinical Criteria Summary
Exclusion Criteria
- Baseline resting corrected QT interval (QTc) >470 msec obtained on more than one consecutive electrocardiogram (ECG) or risk factors (electrolyte abnormalities, heart failure, congenital long QT syndrome, family history of long QT syndrome, concomitant medications known to prolong QTc interval)
- Clinically important abnormalities in cardiac rhythm, conduction or morphology on ECG
- History of Interstitial Lung Disease or clinically active Interstitial Lung Disease
- Lactating status
- Pregnancy
Inclusion Criteria (Indications)
- First-line treatment for metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations
- In combination with pemetrexed and platinum-based chemotherapy for first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations
- Locally advanced or metastatic non-small cell lung cancer with a documented T790M mutation
- Adjuvant therapy after tumor resection for patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations
Additional Inclusion Criteria (Care Setting & Performance Status)
- Care provided by a VA/VA Community Care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Goals of care and role of Palliative Care consult discussed and documented
Additional Inclusion Criteria (Pregnancy & Contraception Counseling)
- Patients who can become pregnant: counseling on potential risks vs benefits of treatment and use of effective contraception during therapy and for 6 weeks after stopping treatment
- Patients with partners who can become pregnant: counseling on potential risks vs benefits and use of effective contraception during therapy and for 4 months after stopping treatment