FDA Approves Atezolizumab for Refractory Metastatic Non-Small Cell Lung Cancer

October 20, 2016

The US Food and Drug Administration (FDA) has approved atezolizumab (Tecentriq®, Genentech) for treating chemotherapy-refractory, metastatic non-small cell lung cancer (NSCLC), Genentech announced.

The US Food and Drug Administration (FDA) has approved atezolizumab (Tecentriq®, Genentech) for treating chemotherapy-refractory, metastatic non-small cell lung cancer (NSCLC), Genentech announced.

Atezolizumab was initially approved by the FDA May 16, 2016, to treat locally advanced or metastatic urothelial carcinoma for those with disease progression during or following platinum-based chemotherapy.

The agency approved atezolizumab for treatment of patients whose NSCLC has progressed despite treatment with platinum-based chemotherapy, and whose tumors harboring EGFR or ALK mutations progressed despite treatment with FDA-approved targeted biologic therapies, the company announced.

Atezolizumab is a monoclonal antibody that binds to programmed cell death ligand 1 protein (PD-L1) on tumor cells and tumor-infiltrating immune cells, thereby allowing activation of T-cell antitumor activity.

The approval follows findings from the randomized phase III OAK and phase II POPLAR clinical trials, indicating a median 4.2-month overall survival (OS) advantage over docetaxel chemotherapy (median OS in OAK trial participants: 13.8 months versus 9.6 months; hazard ratio [HR] = 0.74; 95% CI, 0.63-0.87). OAK study participants included patients with varying PD-L1 status and both squamous and non-squamous NSCLC.

“The approval of Tecentriq is another important step for patients by increasing the number of medicines available to people living with lung cancer,” said lung cancer survivor Bonnie Addario, founder of the Bonnie J Addario Lung Cancer Foundation.

Seven phase III trials of first-line atezolizumab monotherapy or combination therapy for lung cancer treatment are under way, according to Genentech.

Patients should be asked if they are taking over-the-counter or prescription medications, vitamin or herbal supplements. Patients should also be asked about histories of lupus, organ transplantation, myasthenia gravis, or Guillain-Barre syndrome, and if they are currently undergoing treatment for an infection.

Serious side effects associated with atezolizumab include pneumonitis, hepatitis, colitis, neuropathy, meningitis, encephalitis, uveitis (inflammation of the eyes), severe infections and infusion reactions, and hormone gland problems affecting the pancreas, pituitary, thyroid, and adrenal glands.

The most common side effects are fatigue, decreased appetite, shortness of breath, cough, nausea, and constipation.

Patients should be educated to contact healthcare providers immediately if they exhibit any symptoms or worsening symptoms for these immunotherapy-associated toxicities. Patients with these side effects should be treated with corticosteroid or hormone replacement drugs and treatment with atezolizumab should be delayed or halted entirely in severe cases.