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FDA NewsNewsworthy

Tecentriq Now Approved as First Treatment for Advanced Bladder Cancer in Some Patients

On April 17, 2017, the FDA approved the PD-L1 inhibitor Tecentriq (atezolizumab; from Genentech) for use as first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who cannot use cisplatin chemotherapy.
June 2017 Vol 3 No 3

On April 17, 2017, the FDA approved the PD-L1 inhibitor Tecentriq (atezolizumab; from Genentech) for use as first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who cannot use cisplatin chemotherapy. This is the first immunotherapy and the first PD-L1 to receive FDA approval for use as the first treatment for patients with advanced bladder cancer. Tecentriq was first approved in 2016 for locally advanced or metastatic bladder cancer in patients who have received previous therapy.

“It is encouraging to see continued progress in the treatment of advanced bladder cancer, which until last year had not seen any major advancements in more than 30 years. We are excited that Tecentriq is now a treatment option for people with advanced bladder cancer who are unable to receive a cisplatin-based chemotherapy as an initial treatment,” said Andrea Maddox-Smith, Chief Executive Officer, Bladder Cancer Advocacy Network, in a press release.

Serious side effects with Tecentriq include pneumonitis, hepatitis, colitis, hormonal issues, neuropathy, meningitis, encephalitis, and eye inflammation, as well as severe infections and severe infusion reactions.

Tagrisso Receives Full Approval for NSCLC with EGFR T790M Mutation

On March 30, 2017, the FDA granted Tagrisso (osimertinib; from AstraZeneca) full approval for the treatment of metastatic non–small-cell lung cancer (NSCLC) with the EGFR T790M genetic mutation, as detected by an FDA-approved test, in patients whose tumor progressed during or after EGFR tyrosine kinase inhibitor therapy. Tagrisso was given an early and accelerated approval by the FDA in November 2015 for NSCLC with this mutation, with the understanding that a full approval is pending more evidence confirming the safety and efficacy seen with this drug in early clinical trials.

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Last modified: October 5, 2017