Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.
On October 15, 2021, the FDA approved atezolizumab (brand name Tecentriq) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer whose tumors have PD-L1 expression on more than 1% of tumor cells, as determined by an FDA-approved test.
Today, the FDA also approved the VENTANA PD-L1 (SP263) Assay as a companion diagnostic device to select patients with non-small cell lung cancer for adjuvant treatment with Tecentriq.
The major efficacy outcome measure was disease-free survival as assessed by the investigator in the primary efficacy analysis population of patients with stage II-IIIA non-small cell lung cancer with PD-L1 expression on more than 1% of tumor cells. Median disease-free survival was not reached in patients on the atezolizumab arm compared with 35.3 months on the best supportive care arm.
In a pre-specified secondary subgroup analysis of patients with PD-L1 tumor cells of more than 50% stage II-IIIA non-small cell lung cancer, the disease-free survival hazard ratio was 0.43. In an exploratory subgroup analysis of patients with PD-L1 tumor cells 1-49% stage II-IIIA non-small cell lung cancer, the disease-free survival hazard ratio was 0.87.
The most common adverse reactions reported in more than 10% of patients receiving atezolizumab, including laboratory abnormalities, were increased aspartate aminotransferase, blood creatinine, and alanine aminotransferase; as well as hyperkalemia, rash, cough, hypothyroidism, pyrexia, fatigue/asthenia, musculoskeletal pain, peripheral neuropathy, arthralgia, and pruritus.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews are ongoing at the other regulatory agencies.
This review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 6 weeks ahead of the FDA goal date.
Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatFDA.
Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.
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