Roche Gets FDA Priority Review for Application To Expand Tecentriq Label to Early Stage Lung Cancer

Kimberly Redmond  |

Image source: Roche

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

On Tuesday, the Swiss pharmaceutical giant said the FDA is expected to decide by Dec. 1 on its supplemental Biologics License Application (sBLA), which seeks approval to use the checkpoint inhibitor as an adjunct therapy in this expanded indication.

The sBLA is based upon promising interim data from a Phase 3 clinical trial that showed Tecentriq improved disease-free survival in patients with PD-L1-positive early-stage non-small cell lung cancer (NSCLC) following surgery and chemotherapy.

When given after surgery and chemotherapy, the drug lowered the disease recurrence or death risk by 34%, compared to best supportive care, in patients who have Stage II-IIIA NSCLC, the study found. 

Results are not yet available on disease-free survival rates in the overall trial population, which could make physicians wary of using the drug as an adjuvant treatment after surgery, analysts have said.

Tecentriq is currently approved in the US, European Union and other countries for use as a monotherapy or in combination with targeted therapies in several forms of NSCLC, small cell lung cancer, urothelial cancer, breast cancer and liver cancer. It is also approved in the US for BRAF V600 mutation-positive advanced melanoma.

The drug is being evaluated in multiple ongoing and planned trials for other cancers including skin, breast, gastrointestinal, gynecological and head.

In a statement Tuesday, Levi Garraway, Roche’s chief medical officer and head of global product development, said, “New treatment options are urgently needed in early-stage, non-small cell lung cancer to help the nearly 50% of people who experience a recurrence following surgery.”

“Tecentriq is the first cancer immunotherapy to show a clinically meaningful benefit in the adjuvant lung cancer setting and we’re working with the FDA to bring this significant advancement to patients as quickly as possible,” Garraway said.

Roche has reported Tecentriq sales of CHF 3.04 billion ($3.35 billion) in the twelve months ended June 30, 2021.

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Source: Equities News

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