In cooperation with the Food and Drug Administration (FDA), and as a service to our members, SITC will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields of recent approvals in a timely manner. Included in the email from the FDA will be a link to the product label, which will provide the relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, SITC does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:
On December 3, 2019, the Food and Drug Administration approved atezolizumab (TECENTRIQ, Genentech Inc.) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
Efficacy was evaluated in IMpower130 (NCT02367781), a multicenter, randomized (2:1), open-label trial in patients with stage IV non-squamous NSCLC who had received no prior chemotherapy for metastatic disease, but could have received prior EGFR or ALK kinase inhibitor, if appropriate. The trial randomized 724patients (ITT) to receive atezolizumab, paclitaxel protein-bound, and carboplatin, followed by single-agent atezolizumab or to receive paclitaxel protein-bound and carboplatin, followed by maintenance pemetrexed at the investigator’s discretion (control).
The primary efficacy outcome measures were progression-free survival (PFS) by RECIST v1.1 and overall survival (OS) in the subpopulation of patients documented to have no EGFR or ALK genomic tumor aberrations (ITT-WT). In the primary analysis population (ITT-WT, N=681), the estimated median PFS was 7.2 months (95% CI: 6.7, 8.3) for the atezolizumab arm compared to 6.5 months (95% CI: 5.6, 7.4) for the control arm (HR 0.75; 95% CI: 0.63, 0.91; p=0.0024). Median OS were 18.6 months (95% CI: 15.7, 21.1) and 13.9 months (95% CI: 12.0, 18.7), respectively (HR 0.80; 95% CI: 0.64, 0.99; p=0.0384).
The most common adverse reactions (reported in at least 20% of patients) of atezolizumab when administered in combination with other antineoplastic drugs in patients with NSCLC and SCLC were fatigue/asthenia, nausea, alopecia, constipation, diarrhea, and decreased appetite.
The recommended atezolizumab dose for this use is 1200 mg as an intravenous infusion every 3 weeks. When atezolizumab is administered on the same day as chemotherapy, atezolizumab should be given first.
View full prescribing information for TECENTRIQ.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.