FDA Approves Tecentriq for Pretreated NSCLC

The Food and Drug Administration approved adjuvant Tecentriq for patients with PD-L1—positive, stage 2 to 3A non-small cell lung cancer.

The Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) for the treatment of patients with stage 2 to 3A non-small cell lung cancer (NSCLC) whose tumors are PD-L1—positive, after they undergo resection and platinum-based chemotherapy.

The approval was based on findings from the IMpower010 clinical trial, which included 1,005 patients with stage 2 or 3A NSCLC who underwent tumor resection and cisplatin-based adjuvant chemotherapy. Half of the patients enrolled received Tecentriq every three weeks for 16 cycles, while the other half received best supportive care.

The main goal of the trial was to determine if Tecentriq improved disease-free survival (period after a successful treatment during which there are no signs and symptoms of the disease), and it did. The average disease-free survival was not yet reached on the Tecentriq group and was 35.3 months for the best supportive care group.

The most common side effects from Tecentriq, that occurred in 10% or more of patients, were: laboratory abnormalities, increased aspartate aminotransferase, blood creatinine, and alanine aminotransferase — which can point toward impaired liver function — high potassium levels, rash, cough, hypothyroidism, fever, fatigue/asthenia, musculoskeletal pain, peripheral neuropathy, arthralgia and pruritus (dry/itchy skin).

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