Roche Receives FDA Priority Review for Application to Extend Tecentriq Label to Early Lung Cancer

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The US Food and Drug Administration (FDA) has approved the priority review of using Roche Holding AG (OTC: RHHBY) Tecentriq (atezolizumab) to treat certain patients suffering from early-stage non-small cell lung cancer.

On Tuesday, a Swiss pharmaceutical giant said the FDA was expected Decided by December 1st For a supplemental biopharmacy approval application (sBLA) seeking approval for the use of checkpoint inhibitors as an adjunct therapy to this extended indication.

sBLA is based on promising interim data from Phase 3 clinical trials showing that Tecentriq improved patient-free survival. PD-L1 positive early non-small cell lung cancer (NSCLC) After surgery and chemotherapy.

Studies have shown that when given after surgery and chemotherapy, the drug reduced the risk of disease recurrence or death in patients with stage II-IIIA NSCLC compared to best supportive care. rice field.

Results on disease-free survival for the entire study population are not yet available. May alert doctors Analysts have stated that the drug should be used as adjuvant therapy after surgery.

Tecentriq Currently approved In the United States, the European Union, and other countries, it is used as monotherapy or in combination with several forms of targeted therapy for NSCLC, small cell lung cancer, urothelial cancer, breast cancer, and liver cancer. It is also approved in the United States for BRAF V600 mutation-positive advanced melanoma.

The drug has been evaluated in multiple ongoing and planned trials for other cancers such as skin, breast, gastrointestinal, gynecological, and head.

Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, said in a statement Tuesday: Recurrence after surgery. “

“Tecentriq is the first cancer immunotherapy to show clinically significant benefits in the setting of adjuvant lung cancer and is working with the FDA to bring this significant advance to patients as soon as possible.” Garraway said.

Roche reported Tecentriq sales CHF 3.04 billion ($ 3.35 billion) for the 12 months ending June 30, 2021.


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