[13] The most common side effects when used on its own include tiredness, reduced appetite, nausea, vomiting, cough, difficulty breathing, diarrhea, rash, fever, pain in the back, joints, muscles and bones, weakness, itching and urinary tract infection.

[20] PD-L1 can be highly expressed on certain tumors, which is thought to lead to reduced activation of immune cells (cytotoxic T-cells in particular) that might otherwise recognize and attack the cancer.

[13] In April 2016, Roche announced that atezolizumab had been granted fast track status for lung cancer by the U.S. Food and Drug Administration (FDA).

[21] In May 2016, the FDA granted accelerated approval to atezolizumab for locally advanced or metastatic urothelial carcinoma treatment after failure of cisplatin-based chemotherapy.

[23] In 2018, FDA altered the use of atezolizumab as a first-line treatment for metastatic bladder cancer in people who can't receive cisplatin-based chemotherapy and have high levels of PD-L1.

[27] In October 2016, atezolizumab was approved by the FDA for the treatment of people with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy.

[28] This approval was based on two international, randomized, open-label clinical trials (OAK and POPLAR) that demonstrated consistent results in efficacy and safety in a total of 1137 participants with NSCLC.

[29] In August 2018, the FDA updated the prescribing information for atezolizumab to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from people with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible.

[30] In September 2018, it was announced that atezolizumab prolongs survival in extensive stage SCLC treatment, according to study results presented at the 19th World Conference on Lung Cancer (WCLC) in Toronto, Canada.

[31] Atezolizumab, in combination with bevacizumab, paclitaxel, and carboplatin, was approved in the United States in December 2018, for the first-line treatment of people with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations.

[34] Also in March 2019, it was approved in the United States, in combination with carboplatin and etoposide, for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

[35] Approval was based on IMpower133 (NCT02763579), a randomized (1:1), multicenter, double-blind, placebo-controlled trial in 403 participants with ES-SCLC who received no prior chemotherapy for extensive stage disease and had ECOG performance status 0 or 1.

[35] In December 2019, atezolizumab in combination with paclitaxel protein-bound and carboplatin was approved by the FDA for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

[37] Efficacy was evaluated in IMpower110 (NCT02409342), a multicenter, international, randomized, open-label trial in participants with stage IV NSCLC whose tumors express PD-L1 (TC ≥ 1% or IC ≥ 1%), who had received no prior chemotherapy for metastatic disease.

[38] Efficacy was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in participants with locally advanced unresectable or metastatic hepatocellular carcinoma who had not received prior systemic therapy.

[38] In July 2020, it was approved in the United States, in combination with cobimetinib and vemurafenib, for the treatment of people with BRAF V600 mutation-positive unresectable or metastatic melanoma.

[19] Recent report about safety and patient-reported outcomes of atezolizumab plus chemotherapy and bevacizumab shows that this drug combination seems tolerable and with manageable toxicities.