LURBINECTEDIN INJ
Clinical Criteria Summary
Exclusion Criteria
- Immunocompromised patients including known HIV (unless HIV with normal CD-4 counts)
- Absolute neutrophil count (ANC) < 1500 cells/mm3 (unless Duffy null positive) and platelet count <100,000/mm3
- Unmanageable strong or moderate CYP3A Inhibitor drug interaction identified (including grapefruit and Seville oranges)
- Concomitant strong CYP3A inducers
- Moderate-severe hepatic impairment (Child-Pugh score of B/C or NCI Organ Definition Working Group classification unless patient has Gilbert’s syndrome)
- Pregnancy
- Lactating
Indication & Inclusion Criteria
- Metastatic small cell lung cancer with disease progression after platinum-based chemotherapy
- In combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide
Care Setting & Performance Status Requirements
- Care is provided by a VA/VA Community Care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Monitoring & Supportive Care Requirements
- Goals of care and role of Palliative Care consult have been discussed and documented
- Baseline CBC then prior to each administration; baseline LFT’s then periodically as indicated
Reproductive Health & Counseling Requirements
- For females who can become pregnant and males with partners who can become pregnant: Counseling on treatment risks vs benefits and use of effective contraception during and for 7 months after last treatment for women and 4 months for men