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Genitourinary Cancer

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April 13, 2021
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FDA approves Trodelvy for advanced urothelial cancer

FDA approves Trodelvy for advanced urothelial cancer

The FDA today granted accelerated approval to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

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March 19, 2021
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FDA plans public meeting to reevaluate accelerated approvals of cancer drugs

FDA plans public meeting to reevaluate accelerated approvals of cancer drugs

FDA’s Oncologic Drugs Advisory Committee plans to hold a public meeting April 27-29 to review six indications for cancer drugs granted accelerated approval that subsequently failed to show clinical benefit in confirmatory trials.

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March 16, 2021
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FDA grants priority review to belzutifan for renal cell carcinoma subset

FDA grants priority review to belzutifan for renal cell carcinoma subset

The FDA granted priority review to belzutifan for treatment of certain patients with renal cell carcinoma.

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March 10, 2021
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FDA approves Fotivda for renal cell carcinoma subset

FDA approves Fotivda for renal cell carcinoma subset

The FDA approved tivozanib for treatment of adults with relapsed or refractory advanced renal cell carcinoma.

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March 08, 2021
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Genentech withdraws Tecentriq indication for bladder cancer

Genentech withdraws Tecentriq indication for bladder cancer

Genentech voluntarily withdrew atezolizumab’s indication in the United States for patients with platinum-treated metastatic urothelial carcinoma.

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March 02, 2021
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First-line pembrolizumab active in both clear cell, non-clear cell advanced kidney cancer

First-line pembrolizumab active in both clear cell, non-clear cell advanced kidney cancer

Pembrolizumab monotherapy showed promising antitumor activity and durable response rates as initial treatment for both clear cell and non-clear cell advanced renal cell carcinoma.

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February 22, 2021
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AstraZeneca withdraws Imfinzi indication for advanced bladder cancer in US

AstraZeneca withdraws Imfinzi indication for advanced bladder cancer in US

AstraZeneca voluntarily withdrew durvalumab’s indication for treatment of adults with locally advanced or metastatic bladder cancer.

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February 18, 2021
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Adjuvant nivolumab significantly extends DFS in high-risk bladder cancer

Adjuvant nivolumab significantly extends DFS in high-risk bladder cancer

Adjuvant nivolumab extended DFS compared with placebo among patients with high-risk, muscle invasive urothelial carcinoma, according to results of the phase 3 CheckMate 274 trial presented at Genitourinary Cancers Symposium.

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February 17, 2021
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Cabozantinib may be new standard for metastatic papillary kidney cancer

Cabozantinib may be new standard for metastatic papillary kidney cancer

Cabozantinib conferred a significant and meaningful extension of PFS compared with sunitinib in metastatic papillary renal cell carcinoma, according to results of a phase 2 randomized trial presented at Genitourinary Cancers Symposium.

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February 16, 2021
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First-line lenvatinib-pembrolizumab combination improves OS, PFS in advanced kidney cancer

First-line lenvatinib-pembrolizumab combination improves OS, PFS in advanced kidney cancer

The combination of lenvatinib and pembrolizumab significantly prolonged OS and PFS compared with sunitinib among previously untreated patients with advanced renal cell carcinoma, according to results of the phase 3 CLEAR trial.

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